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

Model Number 13827

Device Problem No Flow (2991)

Patient Problem Discomfort (2330)

Event Date 02/03/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Agent contacted technical solutions to report that a prometra ii 20 ml pump was explanted.Further follow up communication confirmed the following timeline: agent reported that the patient had a prior pump revision on (b)(6) 2020.Following the revision, a catheter revision was performed on (b)(6) 2020 as patient alleged intermittent therapy.Agent stated that during this revision, when the pump pocket was opened, it was found that the catheter had a potential cut.Catheter was revised and patient contacted the agent 24 hours after surgery reportedly doing well.However, according to agent, a few days later, the patient reported they felt like they were going through withdrawal again.A reservoir study was performed and a discrepancy was noted.The medicine was taken out of the pump and wasn't put back in.During the revision that occurred on (b)(6) 2021, the "catheter was flowing aggressively and had to be clamped right away.They took the pump, put it on the back table, and refilled it.Filled with saline in or, put it in bath.Primed and bolused twice" in an attempt to get a bead.No bead occurred and the pump was explanted by physician.Mfr 3010079947-2020-00357 was opened to address the pump revision on (b)(6) 2020.Mfr 3010079947-2021-00045 was opened to address the catheter revision that occurred on (b)(6) 2020.

Manufacturer Narrative

Device was returned.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 a bead was formed per design 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 07828
• MDR Report Key: 11396166
• MDR Text Key: 234221299
• Report Number: 3010079947-2021-00062
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(10)27056(17)211021
• 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: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2021
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 27056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention