Cardiac Science Corp. faulted for lapses in validation, CAPA, design history.(MEDICAL DEVICES)

Cardiac Science Corporation, Deerfield, WI Minneapolis District

FDA investigators Joseph Edwin and Aaron Dunbar found that Cardiac Science Corporation had not validated and approved a process whose results could not be fully verified by inspection and test, they wrote on the seven-item 483 issued after their inspection. Changes made to a process since a printed circuit board assembly (PCBA) was released for production were not adequately validated. No documentation was found justifying past or current acceptance of the process, the FDAers judged.

The company agreed with the inspectors' assessment and noted in its response that it was conducting a new manufacturing process validation for PCBAs in accordance with a revised procedure. They had also begun to update a number of other processes and supporting procedures in the Quality System Integration plan in response to the inspection, conducted April 11-26, 2006.

A quantity of PCBAs that should have been quarantined before usage was inadvertently used in finished, distributed automated external defibrillators (AEDs), Edwin and Dunbar found. A second recall had to be initiated to recover these AEDs. The company responded that it was in the process of revising its procedures for nonconforming material "to ensure that all unacceptable material in all locations is identified as such and is physically moved and stored in a quarantine location while awaiting disposition."

No CAPA was opened for a number of complaints received during a five-month period prior to inspection relating to complaints relating to PCBAs. The FDA team noted that Cardiac Science had not opened a CAPA to investigate or evaluate a PCBA supplier as acceptable. The firm felt that a complaint referenced did not warrant a CAPA, but stated that "based on FDA's observation, we will open a CAPA for the complaints."

The company also updated its complaint handling procedures and planned to implement "a mechanism for real-time, closed-loop feedback with our critical suppliers. In addition, we will impose strict controls on poorly performing suppliers per our new Supplier Management procedure."

Procedures to ensure that received products and services conformed to requirements were not implemented. The company changed some inspection acceptance criteria for PCBAs without justification, the FDAers wrote. Cardiac Science replied that it understood written justification was not required to change inspection levels; however, it agreed to amend its procedures to require documentation and justification of sample plan changes on the NCMR form.

Procedures addressing identification of CAPA were not implemented, the inspectors observed. A CAPA stated that the AED would not power up if the battery were removed when the AED was running and the lid was open. However, no revision was found that included this information and no complete evaluation regarding the appropriate follow-up to this problem was done, the 483 stated. The company replied that it was in the process of verifying the content of this CAPA and that it had updated its CAPA process and implemented new tools to manage CAPAs, including incorporating short- and long-term effectiveness checks into the process.

Design verification results were not documented and filed in the design history file. The FDAers found that the firm's Design Software Testing Plan did not reference all the software requirement specifications for the Powerheart Responder ECD. The company said it was in the process of updating its design software testing plan to reference all associated software requirements specifications and reviewing all design documentation for the Powerheart ECD.

Procedures for verifying that design output meets design input were not complete, the FDA team wrote. There was no documentation to provide traceability of the Powerheart ECD design software specification requirements to the specific design software verification testing and results. A traceability matrix was being developed, the firm replied, to demonstrate traceability between software specifications and design software verification testing and results.

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