MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. PROMETRA II 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	08/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint number: complaint (b)(4).
Event or Problem Description
It was reported that the volume of undelivered drug remaining in the drug reservoir was greater than the expected volume based upon the programmed infusion rate.The patient experienced inadequate pain relief.The pump was subsequently explanted.
Event or Problem Description
Representative contacted technical solutions to report underinfusion volume discrepancies.For the first volume discrepancy, the expected volume was 6ml and the actual aspirated volume was 16ml.A few days later, a cap study was performed.The first time they attempted to push dye into the cap nothing was seen at the catheter tip so they attempted to push again and dye was seen exiting the catheter tip.Over a month later, an additional volume discrepancy was alleged with the expected volume being 6.825ml and the actual aspirated volume being 18.5ml.It was additionally confirmed that the patient was not receiving pain relief.The pump was later explanted and replaced.
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 nonconformances, 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 20ml of sterile water for injection and allowing the reservoir's pressure to return the fluid into the syringe.The reservoir was refilled and the cap was flushed with 5ml of sterile water.The pump was programmer with a flow test over a twenty-four hour period.The dispensed volume was 0.0ml.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.Internal complaint number: complaint (b)(4).

• 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: 9419439
• Report Number: 3010079947-2019-00153
• Device Sequence Number: 1725415
• Product Code: LKK
• UDI-Device Identifier: 00810335020082
• UDI-Public: 0100810335020082101992617161201
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

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: 19843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 02/01/2021
• 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