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.Agent reported that the sutures that initially held the pump broke, resulting in the migration.Per the instructions for use of the device, pump migration is a known possible risk of use of the device.Internal complaint number: (b)(4).
|
Agent reported a pump pocket revision and subsequent catheter revision.Agent confirmed that the reason for the pump pocket revision and catheter revision was that the patient's pump migrated.It was confirmed that the pump was initially sutured down, but the sutures broke which resulted in the migration.The pump migration resulted in skin breakdown and discomfort for the patient.It was confirmed that the removed segment of catheter would not be returned, and the original pump was relocated to the new pump pocket.
|