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

Model Number 13827

Device Problems Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint number: (b)(4).

Event Description

It was reported that the catheter connector broke off during catheter revision.Physician was trying to remove the catheter lock from the pump to connect to the new catheter segment, when the catheter connector came out of the pump stem.The physician then put the connector back into the pump stem.She reports she then tested the pump to confirm if it was functional, of which it was confirmed that the pump was functional.However, it was reported that it was decided that her back-up pump would be used and implanted in this patient.

Manufacturer Narrative

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.Device was returned for additional evaluation and investigation.Additional physical investigation was performed on the device, and the alleged issue was confirmed.Visual analysis confirmed the metal tip had been pulled from the rubber cannula on the cap.The metal tip was viewed under magnification, confirming the metal tip had been pulled from the compression sleeve it had been crimp collared to.This crimp collar has been failure strength axial tested.The result of the test found that they are able to resist an axial load of 1.1lb.Statistical analysis showed there is a 95% confidence that 95% of the values are above 9.4 lbs.The cause for the metal tip coming out the cannula is the inadvertent use of excessive force pulling on the catheter access port attachment, inadvertently pulling the metal tip out of the cannula.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: 9495038
• MDR Text Key: 197937461
• Report Number: 3010079947-2019-00162
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: 0100810335020228102382917180622
• 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: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2018
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 23829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 10/03/2019
• Supplement Dates FDA Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention