A review of the device history record for the alleged pump, which includes verification of all steps in the manufacturing of the pump, verification of all final testing performed by/on the pump, verification of sterilization, and packaging was performed.The review did not identify any non-conformances, issues or capas associated with pump function.Device was discarded and was not returned for additional evaluation and investigation.As additional physical investigation was not performed on the device, a definitive root cause could not be determined.Per the instructions for use of the device, the useful life of the prometra programmable pump is dependent on the drug delivery rate.Internal complaint number: (b)(4).
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