07

Nov

2005

Guidant Corp. 483

483, warningletter

0

Recipient:Guidant Corp
Product: TA-200 Thermal Angel Blood and IV Fluid Infusion Warmer
Date:9/22/05

There are no corrective and preventive actions to change design control procedures to identify or prevent memory overflow or similar software programming problems from recurring.

Software used as part of production and the quality system has not been fully validated for its intended use according to an established protocol. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.

Specifically, the software used to capture the RPR (Return Product Report) data which includes return device tracking, failure analysis information, and failure analysis results has not been verified or validated in regards to missing RPR records. There are [Redacted] missing records for which the firm cannot account for the details of the contents of the deleted record, who deleted the record, or why was the record deleted. The RPR records are part of a full e-records system. There are no hardcopy records of the deleted records.

FDA District: Dallas District Office

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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