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 non-conformances, issues or capas associated with pump function.Additional physical investigation was performed on the device, confirming the alleged issue.Visual inspection of the pump did not find any exterior anomalies.Engineering was unable to flush the catheter access port (cap), which would lead to a volume discrepancy, confirming the complaint.The cap and suture ring were removed, and a second decontamination was done.Operation of the pump reservoir function was checked by filling the reservoir with 20 ml of sterile water for injection (swi) and allowing the reservoir's pressure to return the fluid into the syringe.A demand bolus of 0.300 mg with a 1.00 mg/ml concentration over 16 minutes was programmed with a programmer.The pump was able to prime at ambient temperature but not at 37°c.The pump was programmed with a 1.994 mg daily dose multirate flow test over a 24-hour time period at 37°c for 1 day.The dispensed volume was 0.0 ml (0%) of the expected volume.This does not meet the design specification.The root cause for the issue is occlusion in the cap.The cause for the occlusion was lost during the second decontamination.Further analysis is required to determine the root cause of the pump not dispensing the expected volume following the second decontamination.This behavior is indicative of a pump that may fall under the scope of capa 00065.Internal complaint number: (b)(4).
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