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

Model Number 13827

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Discomfort (2330); Inadequate Pain Relief (2388); Sleep Dysfunction (2517); Patient Problem/Medical Problem (2688)

Event Date 09/20/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint number: (b)(4).

Event Description

It was that a patient with an implanted prometra ii 20 ml pump went to the hospital with increased pain and withdrawal symptoms and received treatment for break thru pain after having used more than the expected amount of medication.The patient had the pump explanted and replacement with a larger 40ml pumps due to the alleged over infusion.It was also reported that the patient did feel sleepier than normal previous week.

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 was not 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 specification.The unit flowed at 98% efficiency.As the device performed within specification during the investigation, no definitive root cause could be determined for the alleged issue.Note that the patient's pump was replaced by a medtronic pump.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: 9593305
• MDR Text Key: 185188702
• Report Number: 3010079947-2020-00189
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: 0100810335020228102432017181102
• 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: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2018
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 24320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention