Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Delivered Via United Parcel Service
May 13, 2014
Mr. John C. Marous, President and CEO
Cardiac Assist, Inc.
240 Alpha Drive
Pittsburgh, PA 15238-2906
Dear Mr. Marous:
During an inspection of your firm located in Pittsburgh, Pennsylvania, from January 24, 2014 to February 7, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the TandemHeart PTVA® Blood Pump and TandemHeart Escort Controller and accessories. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), the TandemHeart PTVA® Blood Pump and TandemHeart Escort Controller are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
Our inspection revealed that the TandemHeart Blood Pump is misbranded under Section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information regarding the device that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant deviations include, but are not limited to:
Failure to submit a report to FDA within 30 calendar days of receiving or otherwise becoming aware of information, from any source that reasonably suggests that a device that your firm markets, may have caused or contributed to a death, as required by 21 CFR 803.50(a)(1).
For example, your firm was aware of a complaint in which a patient was placed on the TandemHeart pump which had stopped turning after 10 days of use. Attempts to restart the pump were unsuccessful. (b)(4)and worked as intended with a back-up controller. However, the patient died several days later. Your firm became aware of the event on (b)(4), but did not file an MDR.
If your firm wishes to discuss MDR reportability criteria or to schedule further Communications, it may contact the Reportability Review Team by email at: ReportabilityReviewTeam@fda.hhs.gov.
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm
We have reviewed your firm’s response to the FDA-483, dated February 26, 2014, and determined that it appears sufficient to address the Quality System (QS) deficiencies identified on the FDA-483; however we remind you that it is your firm’s responsibility to adhere to its procedures, as well as applicable federal regulations. Your firm’s voluntary corrections will be further evaluated during the next inspection at your facility.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address all violations included in this Warning Letter.
Your written response should be sent to Richard C. Cherry, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Mr. Cherry at (215) 717-3075 or e-mail at Richard.Cherry@fda.hhs.gov.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Anne E. Johnson
Acting District Director
cc: Pennsylvania State Department of Health
132 Kline Plaza, Suite A Harrisburg, PA 17104
Attention: Director, Division of Primary Care and Home Health Services