Device was returned for additional evaluation and investigation.A review of the device history record, 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 for subject pump was performed.The review did not identify any nonconformances, issues or capas associated with pump function.Additional physical investigation was performed on the device, confirming the alleged issue.The investigation confirmed an issue with the pump's flow.An analysis of the inlet and outlet valves confirmed that the inlet valve required a pull open current that exceeded specification.Internal complaint number: complaint (b)(4).
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Sales representative contacted technical solutions to report a patient's pump that was explanted.Representative stated that initially an underinfusion volume discrepancy was observed, with an expected volume of 14.5ml and an actual aspirated volume was 17ml.Representative reported that the battery level was "ok" and that there were no error messages.When the physician additionally disconnected the pump from the catheter there was significant csf back-flow.The physician then manually pushed saline through the cap port then decided to put saline into the reservoir to run the bolus.Technical solutions instructed the representative to program a pump prime when the catheter was disconnected from the pump, and the doctor saw one small bead form at the end, but it did not drip.The physician determined that the pump should be replaced since there was medication already in the pds which should have pushed additional volume out of the stem.However, the pump was not warmed when it was primed/disconnected from the pump.
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