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	08/01/2022
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
Nurse contacted technical solutions to report an underinfusion volume discrepancy.The patient had been complaining of increased pain over the previous weeks, and when a volume check was performed, the expected volume was 4.898ml and the actual aspirated volume was 18ml.The patient did not report any falls, trauma, or mris.Later communication confirmed that a dye study was performed and the catheter was found to be patent.The pump was later explanted.
Additional Manufacturer Narrative
Corrected information: h3, h6 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 anomaly with the pump's exterior.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 pump was able to prime at ambient temperature and at 37°c.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.Engineering emptied the pump's reservoir and refilled it with a 0.01 m of naoh (sodium hydroxide) solution.The solution is a mild caustic solution that will help decompose proteins and fats, which will easily dissolve in water and be removed from the flow path.After running this naoh solution through the flow path, the pump's flow significantly improved from 0% to 92% efficiency.As noted in the prometra® ii pump 20 ml (b)(4) and prometra® ii pump 40 ml (b)(4)instructions for use (ifu): the prometra® programmable infusion pump system is indicated for intrathecal infusion of drug therapy, including: infumorph ® (preservative free morphine sulfate sterile solution), preservative-free sterile 0.9% saline solution (sodium chloride injection, usp), and baclofen (baclofen injection, intrathecal, 500-2000 mcg/ml).Use of unapproved drugs (e.G., drug cocktails, pharmacy compounded drugs, morphine with preservatives, etc.) with the prometra ii pump could result in pump failure.This pump was reported to contain dilaudid as its primary drug.It is likely that the drug(s) used in the pump affected the flow path and/or the materials located in the interior of the pump.Internal complaint number: complaint (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: 15814213
• Report Number: 3010079947-2022-00192
• Device Sequence Number: 17564461
• Product Code: LKK
• UDI-Device Identifier: 00810335020082
• UDI-Public: (01)00810335020082(10)20228(17)170319
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2022
• 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): 10/17/2022

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: 03/19/2017
• Device Model Number: 11827
• Device Catalogue Number: 11827
• Device Lot Number: 20228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2015
• 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: Female