Sales representative reported a prometra ii 20 ml pump with a volume discrepancy - overinfusion.Patient has had multiple refills, in which the patient notes that there were no issues observed during any of their refills.Patient then began to have symptoms of urinary incontinence and loss of feelings in legs.Patient goes to hospital and gets admitted.Physician goes to hospital and accesses the patient's pump, in which the following volume discrepancy was observed: expected volume: 5 mls, returned volume: 0 mls.The patient has not had any mri exposure.The physician was not sure if the symptoms are as a result of the patient not receiving any therapy or as a result of an overinfusion of medication.The pump was explanted and replaced.
|
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.Although requested, it was confirmed that the alleged device would not be returned for additional evaluation and investigation, as the representative stated that they were not in possession of the device and it subsequently would not be returning.As no investigation was able to be performed on the alleged device, no definitive root cause was able to be determined for the alleged issue.Internal complaint number: complaint (b)(4).
|