Sales representative contacted technical solutions to report a pump that was replaced due to a lack of pain relief.A catheter dye study was performed and showed that the catheter was patent.There were no reported volume discrepancies, but when the pump was removed and put on the back table, no bead was observed at the pump step.The patient never reported any withdrawal symptoms or changes in spasticity.
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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, but the alleged issue could not be confirmed.Visual inspection of the pump did not find any anomalies with the exterior of the pump.Functional analysis of the pump confirmed the pump successfully primed and flowed within design specification.The pump operated as expected.No issues were found.Internal complaint number: (b)(4).
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