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

Model Number	11827
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending completion of device analysis and review of device history record.Internal complaint number: (b)(4).
Event or Problem Description
Agent contacted technical solutions to report a pump replacement due to underinfusion volume discrepancies and unrelieved pain.For the first underinfusion that was observed, the expected volume was 3.621ml and the actual aspirated volume was 6.4ml.Three months later, the patient encountered a second underinfusion volume discrepancy.The expected volume was 3.539ml and the actual aspirated volume was 18ml.A catheter dye study was performed that revealed no problems with the patient's catheter.
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, confirming the alleged issue.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.The reservoir was refilled and the cap was flushed with 5 ml of swi.A demand bolus of 0.300 mg with a 1.00 mg/ml concentration over 16 minutes was programmed with a programmer.The valves were heard clicking, but were very light.The pump successfully primed.The pump was programmed with a 1.994 mg daily dose multi-rate flow test over a 24-hour time period at 37°c for 1 day.The dispensed volume was 0 ml (0%) of the expected volume.The catheter access port and suture ring were removed and the pump was decontaminated a second time.The top cover of the pump was machined off and the valves' "pull open / hold open" currents were measured.The results showed that the current required to pull open both the inlet and outlet valves exceeded the design specification for the valve.The pump failed to flow to specification with both the inlet and outlet valves requiring a pull open current in excess of design specification.Internal complaint number: (b)(4).

• Brand Name: PROMETRA PROGRAMMABLE PUMP
• Common Device Name: IMPLANTABLE INFUSION PUMP
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.; 500 international drive; suite 200; mount olive NJ 07828
• Manufacturer (Section G): FLOWONIX MEDICAL, INC.; 120 forbes blvd; suite 170; mansfield MA 02048
• Manufacturer Contact: james bennett ; 500 international drive; suite 200; mount olive, NJ 07828 ; 9734269229
• MDR Report Key: 12001508
• Report Number: 3010079947-2021-00172
• Device Sequence Number: 3096884
• Product Code: LKK
• UDI-Device Identifier: 00810335020082
• UDI-Public: (01)00810335020082(10)19925(17)161201
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: 12/01/2016
• Device Model Number: 11827
• Device Catalogue Number: 11827
• Device Lot Number: 19925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male