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

Model Number 13827

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Patient Problem/Medical Problem (2688); Swelling/ Edema (4577)

Event Date 03/05/2020

Event Type  Injury  

Manufacturer Narrative

Followed up to confirm the status of pump return, currently pending return.(b)(4).

Event Description

Prometra ii 20 ml pump was explanted due to swelling at spinal incision site.The patient previously had a catheter revision due to the patient shoveling snow before they were cleared to do so.Patient was implanted, not long after had to be revised, went against orders by shoveling snow and disconnected entire catheter from the pump.The patient came back on (b)(6) 2020 with swelling at the site and was explanted.Per follow-up, the reported stated that they were unsure they were unsure if the patient did something again or if it was the pump itself.The physician wanted to know if pump was "leaking or something of that nature." no confirmation was provided if volume check was performed during explant.

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 nonconformances, issues or capas associated with pump function.The device was returned for the allegation of "swelling at spinal incision site." 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 94% efficiency.Two sections of catheter that were returned were confirmed to be patent with both air and sterile water for injection.The reporter's concern that the pump was "leaking or something of that nature" was not confirmed.A definitive root cause for the alleged issue could not be confirmed by the investigation performed as the device functioned per specification.It is possible that the "swelling at spinal incision site" may have been related to patient factors as was the case with a prior catheter revision for the same patient.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
• MDR Report Key: 9853216
• MDR Text Key: 184072365
• Report Number: 3010079947-2020-00225
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(10)25483(17)191217
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2019
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 25483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention