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

Model Number 13827

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Inadequate Pain Relief (2388); Patient Problem/Medical Problem (2688)

Event Date 03/09/2020

Event Type  Injury  

Manufacturer Narrative

A review of the dhr, 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.Pending device return.Internal complaint # (b)(4).

Event Description

On (b)(6) 2020, a prometra ii pump 20 ml was explanted due to underinfusions.The patient experienced two or three underinfusions (dates and expected vs aspirated volumes unknown).The patient has not had any recent mri exposure or traumas to the pump site.Patient has no pain relief.Patient is reportedly in pain because no medication being delivered intrathecal.

Manufacturer Narrative

Additional information: a3, g1 (second address).Corrected information: d9, g1, 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 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 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 successfully primed.The pump was programmed with a 1.994 mg daily dose multirate 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 confirmed that the inlet current required a higher current to pull open than the specification, and the outlet valve failed to produce a readable current signal to measure.This indicates that current needed to pull open far exceeds the design specification for the valve.The cause of the issue was confirmed.The pump failed to flow to specification with both the inlet and outlet valves requiring a higher pull open current than the designed specification.Internal complaint number: (b)(4).

• Brand Name: PROMETRA II PROGRAMMABLE PUMP
• Type of Device: IMPLANTABLE INFUSION PUMP
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.; 500 international drive; suite 200; mount olive, nj
• MDR Report Key: 9857290
• MDR Text Key: 185915400
• Report Number: 3010079947-2020-00219
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(10)25822(17)200323
• Combination Product (y/n): N
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2020
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 25822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 03/09/2020
• Supplement Dates FDA Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention