MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. PROMETRA II PROGRAMMABLE PUMP; IMPLANTABLE INFUSION PUMP

Model Number	16827
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, but the alleged issue could not be confirmed.Visual inspection of the pump did not show any anomalies.Functional analysis of the pump confirmed the pump successfully primed and flowed within design specifications.No issues were found with the pump.Internal complaint number: (b)(4).
Event or Problem Description
Sales representative contacted technical solutions to report a pump replacement due to multiple underinfusion volume discrepancies.At the first volume discrepancy, the expected volume was 22.7ml and the actual aspirated volume was 38.5ml.Around a week later, another underinfusion volume discrepancy was observed with the expected volume being 31.2ml and the actual aspirated volume being 38.5ml.Approximately two weeks after that discrepancy, another volume discrepancy was alleged with the expected volume being 28ml and the actual aspirated volume being 39.7ml.A stethoscope test was performed, and the physician could hear the valves clicking.The patient reported an increase in pain.The next day, a catheter dye study was performed.The patient was put into right lateral position and the catheter was found to be patent.The pump was later replaced.

• Brand Name: PROMETRA II PROGRAMMABLE PUMP
• Common Device Name: IMPLANTABLE INFUSION PUMP
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.; 500 international drive; suite 200; mount olive NJ 07828
• MDR Report Key: 12598314
• Report Number: 3010079947-2021-00284
• Device Sequence Number: 17149690
• Product Code: LKK
• UDI-Device Identifier: 00810335020242
• UDI-Public: (01)00810335020242(10)27479(17)220204
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/04/2022
• Device Model Number: 16827
• Device Catalogue Number: 16827
• Device Lot Number: 27479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention