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 was not 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 specification.The unit flowed at 98% efficiency.As the device performed within specification during the investigation, no definitive root cause could be determined for the alleged issue.Note that the patient's pump was replaced by a medtronic pump.Internal complaint number: (b)(4).
|