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 non-conformances, issues or capas associated with pump function.Device was 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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Physician's assistant (pa) contacted technical solutions to report underinfusion volume discrepancies noticed on a patient's pump.Pa stated that there was an underinfusion volume discrepancy of about 3-4 mls that was seen at the patient's last refill about a month prior.The patient had an x-ray performed around that time which did not show anything abnormal with the catheter.Recently, the patient began reporting withdrawal-like symptoms and the pa noticed another underinfusion volume discrepancy where 15.436 mls were expected and 18 mls were actually aspirated.The patient was reported to have had no recent mri's, falls, or other accidents per the pa's knowledge.Pump was later explanted and replaced with a medtronic pump without a catheter dye study being performed.
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