Sabratek Corp. 8/19/98 Infusion pumps

1. Failure to identify the actions needed to correct and prevent recurrence of non-conforming product. For example, it was determined that the _____ had a software problem which prevented the infusion rate from exceeding the bolus rate while operating in the “PCA” mode. While the software has been revised, the software development process was not reviewed to prevent this type of problem from recurring.

2. Failure to ensure that changes to specifications, processes or procedures are verified or where appropriate validated, before implementation. For example, there was no documentation of the verification or validation that the change to the software (referenced above) was effective. Also, there was no verification or validation that the addition of urethane coating to the CPU board was effective.