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

Model Number 13827

Device Problems Failure to Infuse (2340); No Flow (2991)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/06/2021

Event Type  Injury  

Manufacturer Narrative

Pending completion of device analysis and review of the device history record.Internal complaint number: (b)(4).

Event Description

Sales representative contacted technical solutions to report a pump that was replaced due to a lack of pain relief.A catheter dye study was performed and showed that the catheter was patent.There were no reported volume discrepancies, but when the pump was removed and put on the back table, no bead was observed at the pump step.The patient never reported any withdrawal symptoms or changes in spasticity.

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, but the alleged issue could not be confirmed.Visual inspection of the pump did not find any anomalies with the exterior of the pump.Functional analysis of the pump confirmed the pump successfully primed and flowed within design specification.The pump operated as expected.No issues were found.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: 12263657
• MDR Text Key: 265218161
• Report Number: 3010079947-2021-00224
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)151219(10)20559
• 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
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2015
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 20559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention