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, and packaging for subject pump was performed.The review did not identify any non-conformances, issues or capas associated with pump function.Device was discarded and not returned for additional evaluation and investigation.As additional investigation was not performed on the device, a definitive root cause could not be determined for the alleged issue.Internal complaint number: (b)(4).
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Patient tracking received a tracking form through email reporting a pump replacement surgery.The reason for surgery was reported to be, "no aspiration; pump would not flow." the device was discarded after surgery.Additional communication with the agent covering the issue confirmed that a cap study was performed, during which the lack of aspiration and flow was observed.The patient had reported a loss of therapy.The agent also reported that an under infusion volume discrepancy was observed, although no additional information was available about this discrepancy.When the physician removed the catheter from the patient's pump during surgery, the metal pump stem reportedly dislodged from the outer silicone stem.
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