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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Potential Hemolysis in Red Blood Cells and Whole Blood (Update)

To: Blood Centers
Hospital Transfusion Services
Healthcare Facilities

FDA is updating our safety information originally directed to the healthcare community December 10, 2004 regarding the need for vigilance during the examination of leukocyte reduced red blood cell and whole blood products prior to distribution or issuance for transfusion.

Background

FDA has continued to receive reports of hemolysis of red blood cells and whole blood products following leukocyte reduction using the BPF4 High Efficiency Filter manufactured by Pall Medical. The hemolysis has been reported both immediately following filtration and 24 to 48 hours after filtration.

The investigation to determine the root cause or causes continues.

On 12/17/2004 Pall issued a voluntary recall of 25 lots of filters.

Even if the lots in use in your facility were not included in the recall, you should remain vigilant in examining product manufactured using any of the following Pall product codes: 430-00, 430-41, 430-45, 430-50 and BPFB.

Recommendations

Consistent with the recommendations from Pall Medical to their consignees, we recommend the following steps be taken to minimize risk:

  • Immediately examine your inventory of unused Leukotrap SC RC systems and determine if you have any of the recalled lots in stock.
  • If you do, place these listed lots on hold in quarantine and do not use.
  • If you have further distributed the listed lots to any other processing centers within your organization, please notify them at once of this recall and instruct them to not use the lots, but to place the product on hold in quarantine.

The recall of 12/17/2004 does not extend to any leukoreduced blood products manufactured from the listed lots. All leukoreduced blood products may remain in use with full vigilance to detect hemolysis.

We recommend the continued vigilance by hospitals and other transfusion services in the examination of leukoreduced blood products for hemolysis prior to issuance for transfusion. Full vigilance of products manufactured using the designated Pall filters should minimally include:

  • Examine the plasma layer visible in the integral segments and at the top of the blood bag for evidence of hemolysis prior to distribution and immediately prior to release for transfusion.
  • Store bags upright to enhance settling of the blood which will allow easy examination of the plasma layer.
  • If the blood has been mixed so that the plasma layer cannot be visualized immediately prior to release for transfusion, we recommend a segment be centrifuged and examined prior to release.

If low levels of hemolysis are noted, the decision to use or distribute the unit should be guided by your internal Standard Operating Procedures and the discretion of the Medical Director at each center.

Reporting

  • Continue to report hemolysis, please immediately call Pall Medical at 1-800-645-6578 with the following:
    • Your Facility Name
    • Contact Name and Title
    • Contact Phone Number (office, fax, mobile and/or pager)
    • BPF4 Product Reorder Code(s) Used (430-00, 430-41, 430-45, 430-50, BPFB)
    • For each lot inspected or processed, provide the lot number. (How much of this lot is unused?)
    • If hemolysis is seen, specify where (segment, bag, or both) & color
      If hemolysis is quantified, specify the method (color chart or assay) and the level
    • Frequency (# units hemolyzed / # units inspected or processed)
    • Age of the product at time of filtration
    • From the original product container: the manufacturer and the anticoagulant/additive solution