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

Model Number 13827

Device Problems Pumping Stopped (1503); Failure to Infuse (2340); Battery Problem (2885)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/09/2020

Event Type  Injury  

Manufacturer Narrative

Pending further follow-up, investigation, and review of device history record.Internal complaint number: (b)(4).

Event Description

Sales representative contacted technical solutions in order to report a prometra ii pump with an alleged error code 115.Field clinical engineer (fce) was dispatched to perform a hard reset on the pump.Fce reported that when they inquired the pump they observed error codes 100, 104, and 105 and the battery read as low.An error code 115 was not observed.They reported that they attempted to do a hard reset but were unsuccessful, and once the hard reset failed, the pump could not communicate with the programmer and began to beep.They then reported that for the comfort of the patient they initiated another hard reset in order to stop the beeping, and left the pump in that state.

Manufacturer Narrative

Pending completion of device analysis.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, and packaging for subject pump was performed.The review did not identify any non-conformances, issues or capas associated with pump function.Internal complaint number: complaint (b)(4).

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 an issue.No visible anomalies were found with the exterior of the pump.Functional testing of the unit confirmed the issue.Engineering was unable to inquire the pump.The pump cover was removed to observe the internal components.It was observed that the internal electronics cavity showed signs of corrosion and damage due to moisture.Engineering confirmed a leak from the valve to the baseplate weld.This leak is the cause for the issue.This issue was reviewed and the operator was retrained in the process 0092-00913.The root cause of the issue was determined to be an improper weld of the inlet valve to the baseplate, leading to a leak of fluid into the component cavity.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 07828
• MDR Report Key: 10652787
• MDR Text Key: 210611688
• Report Number: 3010079947-2020-00310
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(10)26671(17)210724
• Combination Product (y/n): N
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2021
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 26671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention