Inspections, Compliance, Enforcement, and Criminal Investigations
Terumo Cardiovascular Systems 31-Aug-06
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
August 31, 2006
Mark A. Sutter
President and CEO
Terumo Cardiovascular Systems
6200 Jackson Road
Ann Arbor, MI 48103
Dear Mr. Sutter:
The Food & Drug Administration (FDA) conducted an inspection of your establishment located in Ann Arbor, Michigan on December 6-9, 2005. The purpose of this inspection was to verify corrections made as a result of a Warning Letter issued to you on August 31, 2004 for violations of Title 21, Code of Federal Regulations, Part 820, the Quality System Regulations. The follow-up inspection resulted in a number of questions and requests for further information concerning several complaints.
The inspectional observations and the requested information provided by your firm revealed that the Advanced Perfusion System (APS-1) devices appear to be misbranded within the meaning of section 502(t)(2) of the Act (21 U.S.C. § 352(t)(2)) in that your firm failed to furnish material or information required by or under section 519 of the Act related to 21 CFR Part 803 - Medical Device Reporting (MDR) Regulation and 21 CFR Part 806 - Correction and Removals Regulation. Significant violations include, but are not limited to, the following:
1. Failure to file adverse event reports within 30 days, as required by Subpart E, the Manufacturer Reporting Requirements of 21 CFR 803. For example, you failed to report to the FDA within 30 days the results of a review and investigation of twelve malfunctions related to failure of the manual pump speed control knob. Because the APS-1 is a life-supporting device, these malfunctions should have been reported in accordance with 21 CFR 803.50(a)(2).
2. Failure to file a report of corrections or removals as required by Subpart B of 21 CFR 806 . For example, your firm failed to promptly report to the FDA, as required by 21 CFR.806.10, the field correction action number NFC 813720, an action performed by your firm to reduce a risk to health posed by the APS-1 device. This field correction included a software update to correct a software defect that could result in incomplete delivery of cardioplegia dose. CDRH evaluation has classified your October 19, 2005 notification to consumers of a software upgrade as a Class II recall indicating a situation in which use of or exposure to the APS-1 presents a remote probability of serious adverse health consequences.
The above is not intended to be an all-inclusive list of deficiencies at your firm. It is your responsibility to assure adherence to each requirement of the federal regulations. Other Federal agencies are advised of the issuance of all Warning Letters about medical devices so that they may take this information into account when considering the award of contracts.
You should take prompt action to correct these violations and prevent reoccurrence in the future. Failure to promptly correct these violations may result in FDA initiating regulatory action without further notice. These actions include, but are not limited to, seizure of your products and/or injunction.
Please notify this office in writing within fifteen (15) working days of your receipt of this letter, of any additional steps you intend to take to bring your firm into Compliance. If corrective actions cannot be completed within 15 working days, please state the reason for the delay and the time frame which the corrections will be implemented. Your written reply should be directed to Paige E. Wilson, Compliance Officer at the above address.
Joann M. Givens
Detroit District Office