Edwards Life Sciences, Irvine, CA, Feb. 5 (Irvine, CA).(MEDICAL DEVICES)

An April 5-Aug. 10, 2006, inspection determined that the investigators from FDA determined that the manufacturer of the Swan-Ganz Continuous Cardiac Output (CCO) Catheter was not in conformance with current GMP requirements of QS regulations for medical devices. Some of the deviations included the following.

First was failure to establish and maintain adequate procedures to analyze all sources of quality data, to investigate the cause of nonconformities, and to identify corrective and preventive actions (CAPAs).

For example, there was no documentation that the numerous open complaints from 2000 to the present were analyzed to identify existing and potential nonconforming product, or to determine whether corrective and preventive actions were necessary.

Next, the letter cited failure to establish and maintain adequate procedures to review, evaluate, and investigate complaints involving the possible failure of a device.

Specifically, during the use of a Swan-Ganz CCO catheter on Dec. 1, 2004, the user received the error message, "catheter verification, use bolus mode." The catheter was re placed with a catheter from a different lot and the device functioned as specified, but no further investigation as to the root cause of the device failure was conducted.

Also noted was failure to ensure that complaints are processed in a uniform and timely manner. Numerous complaints remained open dating as far back as the year 2000, the agency wrote.

For example, a complaint for an optical module dated Aug. 1, 2005, was returned for evaluation on Aug. 15, 2005. The evaluation summary resulted in no fault found.

Next, the company was faulted for failure to establish and maintain adequate procedures and documentation for the design history file (DHF)

For example, the agency stated, packaging Engineering Benchmark Study was initiated by the firm in 2004 and completed in 2005. The purpose of the survey was to justify the change from an ASTM pre-conditioning standard to an ambient pre-conditioning procedure, and to reduce sample size. However, no raw data for the interim report or for the final study results were available for review.

Also, the firm was faulted for failure to establish and maintain adequate procedures for the evaluation, control, and documentation of suppliers.

For example, testing, including, but not limited to: vibration test, drop test, and conditioning, for two protocols were conducted by a supplier in January and February 2006, but the supplier agreement was not signed until April 12, 2006. CAPA; C-H; Doc. 14104W

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