Agent contacted technical solutions to report that a prometra ii 20 ml pump was explanted.Further follow up communication confirmed the following timeline: agent reported that the patient had a prior pump revision on (b)(6) 2020.Following the revision, a catheter revision was performed on (b)(6) 2020 as patient alleged intermittent therapy.Agent stated that during this revision, when the pump pocket was opened, it was found that the catheter had a potential cut.Catheter was revised and patient contacted the agent 24 hours after surgery reportedly doing well.However, according to agent, a few days later, the patient reported they felt like they were going through withdrawal again.A reservoir study was performed and a discrepancy was noted.The medicine was taken out of the pump and wasn't put back in.During the revision that occurred on (b)(6) 2021, the "catheter was flowing aggressively and had to be clamped right away.They took the pump, put it on the back table, and refilled it.Filled with saline in or, put it in bath.Primed and bolused twice" in an attempt to get a bead.No bead occurred and the pump was explanted by physician.Mfr 3010079947-2020-00357 was opened to address the pump revision on (b)(6) 2020.Mfr 3010079947-2021-00045 was opened to address the catheter revision that occurred on (b)(6) 2020.
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Device was returned.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 a bead was formed per design specification.Internal complaint number: (b)(4).
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