Inspections, Compliance, Enforcement, and Criminal Investigations
Medtronic Emergency Response System 09-Jun-05
Department of Health and Human Services
Public Health Service
June 9, 2005
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 05-23
Robert S . White, President
Medtronic Emergency Response System
11811 Willows Road NE
P.O. Box 97006
Redmond, Washington 98073-9706
Dear Mr. White:
On February 23, March 2-4, 7, 9-11, 14-18, 21-25, 28, and 31, 2005, Food and Drug Administration (FDA) investigators conducted an inspection of your establishment located at 11811 Willows Road NE, Redmond, Washington. We acknowledge the receipt of your responses dated April 26, 2005, and May 26, 2005. FDA has determined that your establishment manufacturers the Lifepak 12 (LP 12) defibrillator, which is a medical device under section 201(h) [21 U.S.C. 321(h)] of the Federal Food, Drug, and Cosmetic Act (the Act).
Our inspection revealed that this device is adulterated within the meaning of section 501(h) of the Act [21 U.S.C. 351(h)] in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformance with the current Good Manufacturing Practice (cGMP) requirements for medical devices which are set forth in the Quality System Regulation (QSR), as specified in Title 21, Code of Federal Regulations (CFR), Part 820, as follows:
1. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
A. Specifically, you failed to verify or validate a corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as is required by 21 CFR 820.100(a)(4).
You initiated Field Action 201 (TSU 273) in May 2004 to address the problems found during the problem investigation (P1D) 20030239. The investigation found failures of the therapy connectors due to impact damage; bent, broken, and worn pins in the cable connectors; and broken wiring in the cables. The field action recommended installing a new therapy connector (version[redacted], replacing all therapy cables with new versions, visually inspecting therapy cables for damage, and performing a product inspection procedure. Although these actions were implemented, there have been continued complaints of broken pins in the therapy cables used with the new [redacted] connector, some of which were reported after the application of TSU 273. While the responses dated April 26, 2005, and May 26,.2005, have indicated that further investigation of continued complaints of broken pins will be made, they have not addressed any attempt to determine why the corrective action or the validation of the planned corrective action did not result in one that was fully effective.
B. Specifically, your firm failed to identify the action(s) needed to correct and prevent recurrence of non-conforming product and other quality problems, as required by 21 CFR 820.100(a)(3).
The work instructions for field action TSU 273 did not have a requirement to inspect the cable connections for hard paddles. Four complaints, 20030616, 20030618, 20030694, and 20040254, reviewed by FDA investigators revealed that pre-hospital users have reported broken pins in the hard paddle assemblies. Your responses dated April 26, 2005, and May 26, 2005, have not addressed why the inspection of hard paddle cable connectors used by pre-hospital LP 12 users was not needed or included as part of the TSU 273 field action. Documentation of the investigation and the corrective action does not clearly indicate to us why the hard paddles were not included in the field action.
C. Specifically, your firm failed to analyze processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems, as required by 21 CFR 820.100(a)(1).
Your firm did not open a PID, as required by your own procedures, on complaint no. 20040814, which involved a patient death. Your firm also did not open a PID when there were complaints of broken pins in the therapy cables after the implementation of field action TSU 273 in May 2004. The responses dated April 26, 2005, and May 26,'2005, did not address why the PIDs were not opened as required by your own procedures.
D. Specifically, your firm failed to investigate the cause of nonconformities relating to product, processes, and the quality system, as required by 21 CFR 820.100(a)(2).
Your firm did not complete the investigations of PID 20040057 and PID 20040070, to identify the problems for root cause(s) and planned corrective actions within thirty (30) days, as required by your own procedures. The responses dated April 26, 2005, and May 26, 2005, did not assure us that you have taken any corrective action to make sure investigations are opened when called for by your own procedures.
This letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA.The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations and take prompt actions to correct the violations and to bring your products into compliance.
Federal agencies are advised of the issuance of ail Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, no premarket submissions for Class III devices to which QSR deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no requests for Certificates for Products for Export will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.
Please notify this office within 15 working days of receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to identify and make corrections to any underlying system problems necessary to ensure that similar violations will not recur. Please include any and all documentation to show that adequate correction has been achieved. In the case of future corrections, an estimated date of completion, and documentation showing plans for correction should be included with your response to this letter.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand,Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Lisa M. Elrand at (425) 483-4913.
Charles M. Breen