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American National Red Cross/Biomedical Services, Washington, D.C., September 7, 2006, Adverse Determination Letter and Related Nov. 15th, 2006 Consent Decree Correspondence

 

 ADVERSE DETERMINATION LETTER


Note: Although this is an accurate representation of the original Letter issued to the firm, it is not an exact copy. Slight modifications to the original Letter have been made to accommodate its conversion to the HTML format. A scanned copy of the original letter is available in PDF format at the bottom of this page.

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
FAX: (410) 779-5707

September 7, 2006

 

ADVERSE DETERMINATION LETTER

BY FACSIMILE &
CERTIFIED MAIL
RETURN RECEIPT REQUESTED 

Mr. John F. McGuire
Executive Vice President
Biomedical Services
American National Red Cross
2025 E Street, N.W.
Washington, D.C.  20006

RE:  United States v. American National Red Cross, Civil Action No. 903-0949 (JGP)

Dear Mr. McGuire:

Paragraph X of the Amended Consent Decree of Permanent Injunction (Decree) entered on April 15, 2003 permits the Food and Drug Administration (FDA) to assess a penalty for “each unit of unsuitable blood or blood component that [the American Red Cross (ARC)] distributes after entry of [the Decree] for which FDA determines that the release was preventable by ARC….”  Paragraph X.A.2. of the Decree provides that “[i]f FDA determines that use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote, FDA may assess a penalty of up to $5,000 for each such unit of blood or each such blood component.  Notwithstanding the foregoing, FDA shall not assess ARC under this subparagraph (X.A.2) for the improper release of more than 100 units in any one event.”

FDA has recently completed a review of its database and files to identify classified1 recalls conducted by ARC.  We identified 165 events in which ARC reported to FDA that it retrieved unsuitable blood components that were distributed during the period of April 15, 2003 through April 15, 2005 (this does not include any classified ARC-conducted recalls previously identified in the May 15, 2005 adverse determination letter).  FDA determined that these events were preventable by ARC, that they meet the health hazard criteria of paragraph X.A.2. of the Decree, and that no penalty exception listed in Paragraph X.B. of the Decree applies.  These events involved 12,233 unsuitable blood components.  

Seven of the events involved more than 100 unsuitable blood components but were limited for penalty purposes to 100 units as provided by Paragraph X.A.2. of the Decree.  The total number of unsuitable blood components for which FDA assessed a penalty under Paragraph X.A.2. of the Decree is 1083. 

The unsuitable blood components are listed by event in the attachment to this letter.  The events are identified by ARC-assigned biological product deviation numbers and FDA-assigned recall numbers and are arranged by ARC regions.  The attached list does not include all events that occurred during the specified time period; it includes only those events classified by FDA as of May 1, 2006.  After FDA review, additional penalties may be assessed for events that occurred during the aforementioned time period but are not listed in the attachment.

Paragraph X.A.2. of the Decree sets forth three factors FDA must consider when determining whether to assess a penalty and the amount of a penalty:  “(1) the potential effect of the event on the public health, e.g., the number and seriousness of exposures; (2) ARC’s trends with respect to the same or similar events involving the release of unsuitable products; and (3) the degree to which ARC contributed to the improper release of the blood or blood components.”  FDA has considered these factors and has assessed penalties accordingly for each unsuitable blood component (see attached list).  The total penalty is $4,224,000.   

As provided in the Decree, if ARC agrees with this adverse determination, it must, within 20 days of receipt of this letter, notify FDA of its intent to come into compliance with the Decree, submit a plan to do so, and pay the penalty no later than thirty days (30) thereafter.  If ARC disagrees with FDA’s adverse determination, it shall respond in writing within 20 days of receipt of this letter, explaining the reason(s) for disagreeing with FDA’s determination.  The response must be submitted to me at the Food and Drug Administration, Baltimore District Office, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215, with a copy to Jesse Goodman, M.D., M.P.H., Director, Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N, Rockville, Maryland 20852.

 

Sincerely yours,

[Handwritten Signature]

Evelyn Bonnin
Director, Baltimore District

ATTACHMENT

cc: Mr. John F. McGuire
Interim President and CEO
American National Red Cross
2025 E Street, N.W.
Washington, D.C.  20006

 

C. William Cherry
Senior Vice President for Quality
and Regulatory Affairs
American National Red Cross
2025 E Street, N.W.
Washington, D.C.   20006

 

Mary Elcano
General Counsel
American National Red Cross
2025 E Street, N.W.
Washington, D.C.  20006

 

Bonnie McElveen-Hunter
Chairman, Board of Governors
American National Red Cross
2025 E Street, N.W.
Washington, D.C.  20006

 

  [1] Recall classifications are numerical designations assigned by FDA to indicate the relative degree of health hazard presented by the recalled product. 21 C.F.R. § 7.3(m).

AMERICAN RED CROSS

CLASS II RECALLS FOR THE PERIOD 4/15/03 THROUGH 4/15/05 (EXCLUDING THOSE
PREVIOUSLY ADDRESSED IN THE MAY 15, 2005 PARAGRAPH X ADVERSE DETERMINATION LETTER)

The following regions have no recall information included in this report:

Alabama Region, FDA Registration 1073001
Central Plans, Wichita, KS, FDA Registration 1973042
Gulf Coast, Mobile, AL, FDA Registration 1073005
Midwest, Omaha, NE, FDA Registration 1973037
Northern California, Oakland, CA, FDA Registration 2971430
Puerto Rico, Rio Piedras, PR, FDA Registration 2675945
Tennessee Valley, Nashville, TN, FDA Registration 1073006

 

Region/CFNBiological Product Deviation Number/ Recall NumberNumber of Recalled Products/Product TypeReason for RecallPenalty Amount Per Blood ComponentTotal Penalty Amount
Appalachian  11730102004-035-0621471
B-2423-5
1 – Red Blood CellsFailure to control suspect blood component(s) (inappropriate release-enzyme immunoassay (EIA) positive hepatitis B core)
$5,000
$5,000
Arizona 20729972004-007-0416380
B-1480-5
1 - Red Blood Cells Leukocytes Reduced IrradiatedComponent preparation (discrepant irradiation times documented)
$3,000
$3,000
2004-007-0575401
B-0390-5
6 –Platelets Pheresis Leukocytes ReducedComponent preparation (no confirmation of leukocyte reduction)
$4,000
$24,000
2004-007-0649384
B-1763-5B-1764-5
1 - Platelets Pheresis Leukocytes Reduced
Irradiated
1 – Fresh Frozen Plasma Pheresis
Donor eligibility (Blood Donation Record (BDR) question unanswered)
$3,000
$6,000
Badger-Hawkeye 21730282003-03-20217889
B-1676-4
B-1677-4
B-1678-4
1 - Red Blood Cells Leukocytes Reduced
1 - Platelets Leukocytes Reduced
1 – Fresh Frozen Plasma
Donor eligibility (failure to defer donor for increased risk of infection with hepatitis)
$4,000
$12,000
Carolinas Region 10730072004-012-0715488
B-0999-5
1 - Red Blood Cells Leukocytes ReducedDonor eligibility (travel in malarial risk area)
$4,000
$4,000
2004-012-0505489
B-1019-5
B-1020-5
3 - Red Blood Cells Leukocytes Reduced
1 – Plasma Frozen
Donor eligibility (failure to follow standard operating procedures (SOPs) for donors unable to answer health questions on their own)
$2,000
$8,000
2003-012-0122163
B-2381-5
1 - Platelets Pheresis Leukocytes ReducedDonor eligibility (travel in malarial risk area)
$4,000
$4,000
2003-012-0176772
B-1201-5
1 - Red Blood Cells Leukocytes ReducedTesting (sample tube mislabeling mix-up)
$5,000
$5,000
2003-012-0210391
B-0078-6
3 - Platelets Pheresis Leukocytes ReducedDonor eligibility (travel to malarial risk area)
$4,000
$12,000
2004-012-0343049
B-1953-5
1 - Red Blood Cells Leukocytes ReducedFailure to control suspect blood component(s) (unit not placed on hold when deviation on BDR was found)
$5,000
$5,000
2004-012-0370556
B-0715-6
1 - Red Blood Cells Leukocytes ReducedDonor eligibility (travel in malarial risk area)
$4,000
$4,000
2004-012-0378599
B-2382-5
1 - Red Blood Cells Leukocytes ReducedDonor eligibility (travel in malarial risk area)
$4,000
$4,000
2004-012-0379026
B-2380-5
1 - Red Blood Cells Leukocytes ReducedDonor eligibility (travel in malarial risk area)
$4,000
$4,000
2004-012-0398025
B-0931-6
B-0932-6
1 - Red Blood Cells Leukocytes Reduced
1 – Recovered Plasma
Failure to control suspect blood component(s) (inappropriate release of products from a deferred donor)
$5,000
$10,000
2004-012-0456922
B-0888-6
1 – Red Blood Cells Leukocytes ReducedFailure to control suspect blood component(s) (products were not discarded after discovery of an error on the BDR)
$5,000
$5,000
2004-012-04868895
B-0887-6
1 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel in a malarial risk area)
$4,000
$4,000
2004-012-0544145
B-0716-6
2 – Red Blood Cells Pheresis Leukocytes ReducedDonor eligibility (travel to malarial risk area)
$4,000
$8,000
2004-012-0559097
B-0860-6
1 – Red Blood Cells Leukocytes ReducedFailure to control suspect blood component(s) (intended for validation study)
$5,000
$5,000
2004-012-0577082
B-0885-6
B-0886-6
1 – Red Blood Cells Leukocytes Reduced
1 – Fresh Frozen Plasma
Donor eligibility (BDR question  related to Creutzfeldt Jakob Disease (CJD) was unanswered)
$4,000
$8,000
2004-012-0589867
B-2384-5
1 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel in a malarial risk area)
$4,000
$4,000
2004-012-0603330
B-0175-6
1 – Platelets Pheresis Leukocytes ReducedComponent preparation (platelet yield too high for storage in a single bag)
$4,000
$4,000
2004-012-0631857
B-0738-6
1 – Platelets Pheresis Leukocytes ReducedCollection (failure to follow manufacturer’s instructions)
$3,000
$3,000
2004-012-0719187
B-0994-5
1 – Platelets Pheresis Leukocytes ReducedFailure to control suspect blood component(s) (inappropriate release after noting discrepant information on the apheresis procedure record)
$5,000
$5,000
2005-012-0810629
B-2026-5
1 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel in malarial risk area)
$4,000
$4,000
2005-012-0821156
B-1928-5
1 - Platelets Pheresis Leukocytes ReducedCollection (failure to follow manufacturer’s instructions)
$3,000
$3,000
2005-012-0882462
B-0415-6
17 – Platelets Pheresis Leukocytes ReducedDonor eligibility (travel in malarial risk area)
$4,000
$68,000
2005-012-0931808
B-0452-6
B-0453-6
1 – Red Blood Cells Leukocytes Reduced
3 – Platelets Pheresis Leukocytes Reduced
Donor eligibility (travel in malarial risk area)
$4,000
$16,000
2004-012-0358460
B-0867-6
B-0868-6B-0869-6
B-0870-6B-0871-6
B-0872-6
B-0873-6
7 - Red Blood Cells  Leukocytes Reduced
4 – Red Blood Cells Pheresis Leukocytes Reduced
6 – Platelets Pheresis Leukocytes Reduced
4 – Platelets Pheresis Leukocytes Reduced Irradiated
2 – Plasma Frozen Cryoprecipitate Reduced
2 – Cryoprecipitate AHF
4 – Recovered Plasma
Failure to control suspect blood component(s) (units not placed on hold when deviation on BDRs were found)
$5,000
$145,000
Central Ohio 15730132004-016-0431548
B-2005-4
 1  - Platelets Pheresis Leukocytes Reduced IrradiatedFailure to control suspect blood component(s) (inappropriate release after discovery of low platelet yield)
$5,000
$5,000
2004-016-0449876
B-2012-4
2 – Red Blood Cells Leukocytes ReducedDonor eligibility (quality control (QC)for Hemastat could not be verified)
$3,000
$6,000
Connecticut
1273014
B-0116-52 – Red Blood Cells Pheresis – Split UnitComponent preparation (failure to perform quality control testing)
$3,000
$6,000
B-0541-51 – Red Blood Cells PheresisFailure to control suspect blood component(s) (low volume Red Blood Cells)
$5,000
$5,000
B-1237-5
B-1238-5
B-1239-5
B-1240-5
2 – Red Blood Cells Leukocytes Reduced
2 – Platelets Leukocytes Reduced
2 – Fresh Frozen Plasma
2 – Recovered Plasma
Donor eligibility (travel in a CJD risk area)
$4,000
$32,000
Great Lakes 18730332004-018-0386370
B-1672-4
1 – Platelets Pheresis Leukocytes ReducedFailure to control suspect blood component(s) (product intended for validation study)
$5,000
$5,000
2004-018-0474355
B-0067-5
B-0068-5
1 – Red Blood Cells Leukocytes Reduced
1 – Recovered Plasma
Failure to control suspect blood component(s) (sterility may have been compromised)
$5,000
$10,000
2004-018-0503561
B-0072-5
B-0073-5
1 – Red Blood Cells Leukocytes Reduced
1 – Fresh Frozen Plasma
Donor eligibility (failure to follow up on medications taken by donor)
$2,000
$4,000
2004-018-0631286
B-0549-5
1 – Red Blood Cells Leukocytes ReducedDonor eligibility (hematocrit result was not documented)
$3,000
$3,000
2004-018-0687247
B-0595-5
1 – Red Blood Cells Leukocytes ReducedDonor eligibility (hemoglobin was unsatisfactory and hematocrit not documented)
$3,000
$3,000
2005-018-0751704
B-1112-5
B-1113-5
2 – Red Blood Cells Leukocytes Reduced
1 – Fresh Frozen Plasma
Donor eligibility (failure to follow SOPs for travel outside the U.S.)
$4,000
$12,000
2005-018-1081407
B-0587-6
1 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel in malarial risk area)
$4,000
$4,000
2005-018-1008818
B-0602-6
2 – Red Blood Cells PheresisCollection (sterility may have been compromised and failure to follow manufacturer’s instructions)
$5,000
$10,000
Greater Alleghenies 2573016B-0208-51 – Platelets Pheresis Leukocytes ReducedComponent preparation (failure to determine white blood cell count and failure to follow manufacturer’s instructions)
$4,000
$4,000
B-0209-52 – Platelets Pheresis Leukocytes ReducedDonor eligibility (failure to defer donor for taking Feldene)
$2,000
$4,000
B-0904-51 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel in malarial risk area)
$4,000
$4,000
B-0924-51 – Red Blood Cells Pheresis Leukocytes ReducedFailure to control suspect blood component(s) (unit not tagged for hematocrit testing after device malfunction)
$5,000
$5,000
B-1337-5
B-1338-5
1 – Red Blood Cells Leukocytes Reduced
1 – Cryoprecipitated AHF
Donor eligibility (failure to defer donor for taking Avodart)
$5,000
$10,000
B-1396-51 – Platelets Pheresis Leukocytes ReducedComponent preparation (platelet yield too high for single bag)
$4,000
$4,000
B-1890-5
B-1891-5
B-1892-5
2 – Red Blood Cells Leukocytes Reduced
1 – Fresh Frozen Plasma
2 – Recovered Plasma
Donor eligibility (failure to defer donor for CJD risk)
$4,000
$20,000
B-1944-51 – Red Blood Cells Leukocytes ReducedDonor eligibility (failure to defer donor who reported taking medication on the Medication Deferral List)
$5,000
$5,000
B-0320-6B-0313-6B-0317-6
B-0311-6
B-0314-6
B-0315-6
B-0318-6
B-0312-6B-0316-6
B-0319-6
B-0321-6
1 – Red Blood Cells CPDA-1 for Manufacturing Non-Injectables
2 – Red Blood Cells Pheresis Leukocytes
Reduced
3 – Liquid Plasma
2,121 – Red Blood Cells Leukocytes Reduced
278 – Platelets Leukocytes Reduced
1 – Platelet Pheresis Leukocytes Reduced
176 – Cryoprecipiated AHF
36 – Red Blood Cells Leukocytes Reduced Irradiated
332 – Fresh Frozen Plasma
44 – Plasma Cryoprecipitated AHF
1755 – Recovered Plasma
Donor eligibility (use of obsolete CJD information form )
$4,000 for each of 100 blood components
$400,000
Greater Chesapeake and Potomac 11730112004-053-0420855
B-0480-5
1 – Red Blood Cells Leukocytes ReducedDonor eligibility ( BDR question pertaining to Avodart unanswered)
$5,000
$5,000
2004-053-0571810
B-0763-5
1 - Red Blood Cells Leukocytes ReducedDonor eligibility ( failure to defer donor for taking Tazorac)
$2,000
$2,000
2004-053-0560252
B-0765-5
3 – Platelets Pheresis Leukocytes ReducedDonor eligibility (travel in malarial risk area)
$4,000
$12,000
2004-053-0517279
B-0766-5
2 – Platelets Pheresis Leukocytes ReducedDonor eligibility (travel in malarial risk area)
$4,000
$8,000
2004-053-0580808
B-0841-5
B-0842-5
1 – Red Blood Cells Leukocytes Reduced
1 – Recovered Plasma
Donor eligibility (failure to defer donor for history of hepatitis)
$4,000
$8,000
2004-053-0689598
B-1580-5
B-1581-5
1 – Red Blood Cells Leukocytes Reduced
1 – Fresh Frozen Plasma
Failure to control suspect blood component(s) (quarantine error with overweight unit)
$5,000
$10,000
Greater Ozarks-Arkansas
2372998
2004-055-0413840
B-2020-5
B-2021-5
1 – Red Blood Cells Leukocytes Reduced
1 – Fresh Frozen Plasma
Donor eligibility (failure to defer donor for hepatitis risk)
$4,000
$8,000
2003-055-0219886
B-2073-5
4 – Fresh Frozen PlasmaFailure to control suspect blood component(s) (inappropriate release after discovering clots in red blood cells)
$5,000
$20,000
2003-055-0280152
B-2121-5
156 – Platelets Pheresis Leukocytes ReducedComponent preparation (failure to perform monthly QC for platelet pheresis products)
$3,000 for each 100 blood components
$300,000
2003-055-0136101
B-2202-5
1 – Red Blood Cells Leukocytes ReducedFailure to control suspect blood component(s) (inappropriate release after reactive West Nile pool was reported)
$5,000
$5,000
2005-055-0953356
B-0689-6
B-0691-6
B-0692-6
5 – Red Blood Cells Leukocytes Reduced
1 – Fresh Frozen Plasma
3 – Recovered Plasma
Donor eligibility (failure to defer donor for hepatitis risk)
$4,000
$36,000
Heart of America 14730432004-040-0643167
B-0465-5
1 – Platelets Pheresis Leukocytes ReducedFailure to control suspect blood component(s) (sterility may have been compromised)
$5,000
$5,000
2004-040-0642930
B-0466-5
3 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel in malarial risk area)
$4,000
$12,000
2004-040-0642994
B-0467-5
3 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel in malarial risk area)
$4,000
$12,000
2005-040-0804626
B-1327-5
B-1328-5
1 – Platelets Pheresis Leukocytes Reduced
1 – Platelets Pheresis Leukocytes Reduced Irradiated
Collection (failure to follow manufacturer’s instructions)
$3,000
$6,000
2005-040-0886454
B-1679-5
3 – Red Blood Cells Leukocytes ReducedDonor eligibility (failure to document  the hematocrit reading)
$3,000
$9,000
2005-040-1175515
B-0728-6
1 – Red Blood CellsDonor eligibility (travel in malaria risk area)
$4,000
$4,000
Indiana-Ohio 18730312005-038-0799491
B-1104-5
1 – Red Blood CellsFailure to control suspect blood component(s) (inappropriate release after receiving post donation information)
$5,000
$5,000
2004-038-0348688
B-1114-5
B-1115-5
B-1116-5
B-1118-5
B-1119-5
B-1120-5
4 – Red Blood Cells
189 - Red Blood Cell, Leukocytes Reduced
18 – Platelets
1 – Platelets Irradiated
30 - Fresh Frozen Plasma
141 - Recovered Plasma
Donor eligibility (use of obsolete SOP for CJD risk)
$4,000 for each of 100 blood components
$400,000
2005-038-0867114
B-1815-5
1 - Red Blood Cells Leukocytes ReducedDonor eligibility (travel to malarial risk area)
$4,000
$4,000
Lewis and Clark 30729902003-020-0079860
B-0721-6
 
1 – Red Blood Cells Leukocytes Reduced
Donor eligibility  (BDR question unanswered)
$3,000
$3,000
2003-020-0221986
B-0211-6
B-0212-6
B-0213-6
2 – Fresh Frozen Plasma
1 – Plasma Cryoprecipitated Reduced
1 – Cryoprecipitated AHF
Failure to control suspect blood component(s) (inappropriate release after discovery of clots in red blood cells)
$5,000
$20,000
2003-020-0279664
B-0630-6
B-0631-6
34 – Platelets Pheresis Leukocytes Reduced
5 – Platelets Pheresis Leukocytes Reduced Irradiated
Component preparation (failure to perform QC testing)
$3,000
$117,000
Mid-Atlantic 11730242004-029-0594370
B-0445-5
1 – Platelets Pheresis Leukocytes Reduced IrradiatedComponent preparation (volume too great for one collection bag)
$4,000
$4,000
2004-029-0606242
B-0461-5
B-0462-5
1 – Red Blood Cells Leukocytes Reduced
1 – Frozen Plasma
Donor eligibility (failure to defer donor for CJD risk)
$4,000
$8,000
2004-029-0700521
B-1538-5
1 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel in malarial risk area)
$4,000
$4,000
Missouri-Illinois 19730352005-011-0797069
B-0638-6
1 - Red Blood Cells Leukocytes ReducedDonor eligibility (donor incorrectly removed from the National Donor Deferral Registry)
$5,000
$5,000
2005-011-0793209
B-0684-6
1 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel in malaria risk area)
$4,000
$4,000
New England 1270026B-1888-41 – Platelets Pheresis Leukocytes ReducedCollection (failure to follow manufacturer’s instructions)
$3,000
$3,000
B-0501-51 – Red Blood CellsDonor eligibility (travel in malarial risk area)
$4,000
$4,000
B-0502-51 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel in malarial risk area)
$4,000
$4,000
B-0670-51 – Platelets Pheresis Leukocytes Reduced IrradiatedCollection (sterility may have been compromised and failure to follow manufacturer’s instruction)
$5,000
$5,000
B-0723-51 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel in malaria risk area)
$4,000
$4,000
B-0947-52 - Platelets Pheresis Leukocytes ReducedCollection (sterility may have been compromised and failure to follow manufacturer’s instructions)
$5,000
$10,000
B-0951-51 - Red Blood Cells Leukocytes ReducedDonor eligibility (travel in malarial risk area)
$4,000
$4,000
B-0956-51 – Red Blood CellsDonor eligibility (travel in malaria risk area)
$4,000
$4,000
B-1006-51 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel in malaria risk area)
$4,000
$4,000
B-1007-51 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel in malaria risk area)
$4,000
$4,000
B-1009-51 – Platelets Pheresis Leukocytes ReducedDonor eligibility (failure to defer donor for taking Proscar)
$5,000
$5,000
B-1023-51 – Fresh Frozen PlasmaFailure to control suspect blood component(s) (inappropriate release after discovery of clots in red blood cells)
$5,000
$5,000
B-1996-5
B-1997-5
2 – Red Blood Cells Leukocytes Reduced
1 – Fresh Frozen Plasma
Donor eligibility (failure to defer donor for taking Proscar)
$5,000
$15,000
B-2005-51 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel in malaria risk area)
$4,000
$4,000
B-0625-61 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel in malaria risk area)
$4,000
$4,000
New York-Penn 24384452004-001-0532479
B-2253-5
B-2254-5
1 – Red Blood Cells Leukocytes Reduced
1 – Recovered Plasma
Donor eligibility (failure to defer donor for hepatitis risk)
$4,000
$8,000
North Central
2173038
2003-017-0112629
B-0424-6
1 – Platelets Leukocytes ReducedDonor eligibility (failure to defer donor for HIV risk)
$5,000
$5,000
2003-017-0114568
B-0503-6
1 – Platelets Leukocytes ReducedComponent preparation (sterility may have been compromised)
$5,000
$5,000
2004-017-0320991
B-1097-6
1 – Red Blood Cells Leukocytes ReducedFailure to control suspect blood component(s) (overweight unit)
$5,000
$5,000
2004-017-0464920
B-1113-6
1 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel to malarial risk area)
$4,000
$4,000
2004-017-0466796
B-1131-6
2 – Red Blood Cells Leukocytes Reduced 
Component preparation (failure to assure leukoreduction)
$4,000
$8,000
Northeastern Pennsylvania
2573018
B-0069-51 – Red Blood Cells Leukocytes ReducedDonor eligibility (hemoglobin not documented)
$3,000
$3,000
B-0671-51 – Whole BloodDonor eligibility (failure to defer donor for urinary tract infection)
$4,000
$4,000
B-0656-52 – Red Blood Cells Leukocytes ReducedCollections (error on daily quality control record)
$3,000
$6,000
B-1853-51 – Red Blood CellsFailure to control suspect blood component(s) (OC was not properly performed on the hematocrit centrifuge)
$5,000
$5,000
B-1852-51 – Red Blood Cells Leukocytes ReducedDonor eligibility (failure to have a hematocrit value on the BDR)
$3,000
$3,000
B-2375-5
B-2376-5
1 – Red Blood Cells Leukocytes Reduced
1 – Cryoprecipitate AHF
Donor eligibility (failure to defer donor with melanoma)
$4,000
$8,000
B-0233-61 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel in malarial risk area)
$4,000
$4,000
Northern Ohio 15730192004-042-0686603
B-2141-5
B-2142-5
B-2143-5B-2144-5B-2145-5
B-2146-5
B-2147-5
6 – Red Blood Cells
719 – Red Blood Cells Leukocytes Reduced
1 – Red Blood Cells Leukocytes Reduced Washed
50 – Red Blood Cells Apheresis Leukocytes Reduced
249 – Platelets Leukocytes Reduced
107 – Fresh Frozen Plasma
15 – Plasma
Donor eligibility (inadequate donor screening)
$5,000 for each of 100 blood components
$500,000
2005-042-0931991
B-0158-6
1 – Platelets Pheresis Leukocytes ReducedDonor eligibility (travel in malarial risk area)
$4,000
$4,000
Pacific Northwest 30729962003-021-0223957
B-0492-5
1 – Red Blood Cells Leukocytes ReducedCollection (sterility may have been compromised and failure to follow manufacturer’s instructions)
$5,000
$5,000
2004-021-0292966
B-1407-5
1 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel to malarial risk area)
$4,000
$4,000
2004-021-0308462
B-1426-5
1 – Red Blood Cells Leukocytes ReducedDonor  eligibility (travel to malarial risk area)
$4,000
$4,000
2004-021-0346465
B-0479-6
B-0480-6
1 – Red Blood Cells Leukocytes Reduced
5 – Platelets Pheresis Leukocytes Reduced
Donor eligibility (travel to malaria risk area)
$4,000
$24,000
Penn-Jersey 2573021B-2037-41 – Red Blood Cells PheresisComponent preparation (sterility may have been compromised and failure to follow manufacturer’s instructions)
$5,000
$5,000
B-2051-41 – Red Blood Cells PheresisComponent preparation (sterility may have been compromised and failure to follow manufacturer’s instructions)
$5,000
$5,000
B-0819-55 – Red Blood Cells Leukocytes ReducedCollections (daily QC of Hematastat was unacceptable)
$3,000
$15,000
B-0834-5B-0835-55 – Red Blood Cells Leukocytes Reduced Irradiated
6 – Platelets Pheresis Leukocytes Reduced Irradiated
Component preparation (discrepant irradiation times documented)
$3,000
$33,000
B-1434-5
B-1435-5
221 – Platelets Pheresis Leukocytes Reduced
 27 – Platelet Pheresis Leukocytes Reduced Irradiated
Component preparation (monthly QC of pheresis products not performed)
$3,000 for each of 100 blood components
$300,000
B-1531-5
B-1532-5B-1533-5
1976 – Platelets Pheresis Leukocytes Reduced
 736 – Platelets Pheresis Leukocytes Reduced Irradiated
1635 – Fresh Frozen Plasma
Component preparation (manufacturer’s instructions were updated but written procedures had not been updated)
$4,000 for each of 100 blood components
$400,000
B-1542-5
B-1543-5
1 – Red Blood Cells Leukocyte Reduced
1 – Fresh Frozen Plasma
Failure to control suspect blood component(s) (failure to quarantine components after receiving post
donation information)
$5,000
$10,000
B-1749-51 – Red Blood CellsFailure to control suspect blood component(s) (overweight units)
$5,000
$5,000
B-1881-51 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel to malarial risk area)
$4,000
$4,000
B-1882-51 – Platelets Leukocytes ReducedDonor eligibility (failure to defer donor for HIV risk)
$5,000
$5,000
B-1906-513 – Platelets Pheresis Leukocytes ReducedStorage/Shipping (shipment of products exceeded time allowed for shipping)
$4,000
$52,000
River Valley 10730032004-024-0324987
B-1759-5
B-1760-5
730 – Platelets Leukocytes Reduced
90 – Platelets Leukocytes Reduced Irradiated
Component preparation (low platelet yields)
$4,000 for each of 100 blood components
$400,000
South Carolina
1073009
2003-036-0157079
B-0965-6
1 – Red Blood Cells Leukocytes ReducedDonor eligibility (failure to defer donor for taking Lupron)
$2,000
$2,000
2005-036-0859145
B-1009-6
5 – Platelets Pheresis Leukocytes ReducedStorage/Shipping (time in transit not documented)
$2,000
$10,000
2005-036-0978405
B-0921-6
1 – Red Blood Cells Leukocytes ReducedDonor eligibility (failure to defer donor for lymphoma)
$4,000
$4,000
Southeastern Michigan 18730442004-013-0403966
B-1424-5
1 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel to malarial risk area)
$4,000
$4,000
2004-013-0652182
B-1425-5
1 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel to malarial risk area)
$4,000
$4,000
2004-013-0514574
B-1454-5
B-1455-5
B-1456-5
1 - Red Blood Cells Leukocytes Reduced
1 – Platelets Leukocytes Reduced
1 – Fresh Frozen Plasma
Donor eligibility (failure to defer donor for human T lymphotropic virus (HTLV) risk)
$4,000
$12,000
2004-013-0588706
B-1483-5
1 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel to malarial risk area)
$4,000
$4,000
2005-013-0813171
B-2292-5
B-2293-5
1 – Red Blood Cells Leukocytes Reduced
1 – Fresh Frozen Plasma
Donor eligibility (failure to deter donor for taking Avodart)
$5,000
$10,000
2005-013-0979194
B-0015-6
1 – Platelets Pheresis Leukocytes Reduced IrradiatedDonor eligibility (travel to malarial risk area)
$4,000
$4,000
2005-013-0948006
B-0038-6
B-0039-6
1 – Red Blood Cells Leukocytes Reduced
1 – Platelets Leukocytes Reduced
Donor eligibility (travel to malarial risk area)
$4,000
$8,000
2004-013-0414712
B-0124-6
1 – Red Blood Cells Leukocytes ReducedDonor eligibility (failure to defer donor for HTLV risk)
$4,000
$4,000
Southern
1073000
2003-003-0268123
B-0445-6
3 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel in malarial risk area)
$4,000
$12,000
2003-003-0137009
B-0447-6
10 – Red Blood Cells Leukocytes ReducedFailure to control suspect blood component(s) (overweight unit)
$5,000
$50,000
2003-003-0171218
B-0519-6
1  Red Blood Cells Leukocytes ReducedDonor eligibility (travel in malarial risk area)
$4,000
$4,000
2004-003-0655027
B-0736-6
1 – Platelets Pheresis Leukocytes ReducedComponent preparation (inappropriate release of unit with unacceptable platelet yield)
$4,000
$4,000
2004-003-0362554
B-0737-6
1 – Platelets PheresisComponent preparation (inappropriate release of unit with unacceptable platelet yield)
$4,000
$4,000
2004-003-0508176
B-0762-6
1 – Platelets Pheresis Leukocytes ReducedComponent preparation (inappropriate release of unit with unacceptable platelet yield)
$4,000
$4,000
2004-003-0366103
B-0807-6
1 – Platelets PheresisFailure to control suspect blood component(s) (BDR questions related to HIV risk were unanswered)
$5,000
$5,000
2004-003-0591717
B-0895-6
3 – Plasma FrozenFailure to control suspect blood component(s) (inappropriate release after discovering clots in red blood cells)
$5,000
$15,000
2004-003-0424198
B-0896-6
1 – Platelets Pheresis Leukocytes ReducedComponent preparation (inappropriate release of unit with unacceptable platelet yield)
$4,000
$4,000
2004-003-0577474
B-0947-6
2 – Platelets Pheresis Leukocytes ReducedFailure to control suspect blood component(s) (product did not meet product specifications)
$5,000
$10,000
2004-003-0339931
B-1008-6
1 – Red Blood Cells Leukocytes ReducedFailure to control suspect blood component(s) (BDR high risk question unanswered)
$5,000
$5,000
Southern California 20729942003-006-0186567
B-0624-4
1 – Red Blood Cells Leukocytes Reduced
 
Storage/Shipping (product stored at incorrect temperature)
$4,000
$4,000
2004-006-036788
B-1045-5
2 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel to malarial risk area)
$4,000
$8,000
2004-006-0360704
B-1049-5
B-1050-5
2 – Red Blood Cells
1 – Fred Frozen Plasma
Donor eligibility (failure to defer donor for body piercing)
$4,000
$12,000
2004-006-0325150
B-1768-5
B-1769-5
5 – Platelets Pheresis Leukocytes Reduced
1 – Platelets Pheresis Irradiated
Component preparation (failure to perform product QC testing)
$3,000
$18,000
2004-006-0321033
B-1910-5
1 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel to malarial risk area)
$4,000
$4,000
2003-006-0230785
B-0277-6
2 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel to malarial risk area)
$4,000
$8,000
2004-006-0375556
B-0672-6
1 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel to malarial risk area)
$4,000
$4,000
2003-006-0155824
B-0834-6
1 – Platelets Pheresis IrradiatedFailure to control suspect blood component(s) (inappropriate release-elevated platelet count)
$5,000
$5,000
2004-006-0501165
B-1176-6
1 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel to malarial risk area)
$4,000
$4,000
Southwest 16730402003-0490152156
B-1652-5
B-1653-5
1 – Red  Blood Cells Leukocytes Reduced
1 – Recovered Plasma
Donor eligibility (failure to defer donor for taking Proscar)
$5,000
$10,000
2003-049-0226992
B-1680-5
1 – Red Blood Cells Leukocytes ReducedDonor eligibility (failure to defer donor for low Hct)
$3,000
$3,000
2004-049-0709793
B-1698-5
1 – Platelets Pheresis Leukocytes ReducedCollection (sterility may have been compromised)
$5,000
$5,000
2003-049-0182598
B-1699-5
1 – Red Blood Cells Leukocytes ReducedDonor eligibility (failure to defer donor for unacceptable hemoglobin level)
$3,000
$3,000
2004-049-0564594
B-1726-5
1 – Red Blood Cells Leukocytes ReducedDonor eligibility (travel to malarial risk area)
$4,000
$4,000
2004-049-0620192
B-1739-5
2 – Platelets Pheresis Leukocytes ReducedFailure to control suspect blood component(s) (product intended for validation study)
$5,000
$10,000
2005-049-0819904
B-0877-6
1 – Red Blood CellsDonor Eligibility (BDR question pertaining to CJD was unanswered)
$4,000
$4,000
Western Lake Erie 15730202004-050-0305012
B-0082-6
B-0083-6
B-0084-6
1 – Red Blood Cells Leukocytes Reduced
1 – Cryoprecipitated, AHF
1 – Recovered Plasma
Donor eligibility (failure to defer donor for CJD risk)
$4,000
$12,000
2004-050-0654999
B-1000-6
B-1001-6
B-1002-6
1 – Red Blood Cells Leukocytes Reduced
1 – Cryoprecipitated AHF
1 – Recovered Plasma
Donor eligibility (failure to defer donor for hepatitis risk)
$4,000
$12,000

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