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

Model Number 91827

Device Problems Vibration (1674); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Inadequate Pain Relief (2388)

Event Date 10/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was originally seen for a pocket revision due to the pump flipping, but upon opening the pocket, it appeared the pump pocket was infected.The patient did not report any redness or itchiness at the pocket.The pump and catheter were reported to be explanted.

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 non-conformances, issues or capas associated with pump function.Additional physical investigation was performed on the device, but the alleged issue could not be confirmed by the investigation that was performed.An investigation showed that the pump primed and flowed within specification.Continued analysis was unable to confirm any vibration from the pump.Vibration of the pump is not a normal characteristic of the pump.A likely reason for any vibration of the pump may be a loose component located in within the pump can.However, no loose components were observed during the analysis.The issue could not be replicated.Potential root cause for the alleged vibration and potential infection could not be identified.Infection is noted as a possible risk associated with the pump and/or catheter in the instructions for use.Internal complaint number: (b)(4).

Event Description

Representative reported a patient who complained that their pump was not working following a fall.The patient allegedly reported a lack of pain relief and a vibration feeling and fluid around the pump.During the catheter revision to correct the catheter migration, a "yellowish fluid substance" was found surrounding the catheter and pump sites.Representative reported both the catheter and pump were removed as physician did not know if there was an infection.Per follow-up, representative reported, "lab results came back no anaerobic growth in day 2 or 3.Office does not know why patient said it vibrated as they did not feel anything.".

• Brand Name: PROMETRA PROGRAMMABLE PUMP II
• Type of Device: IMPLANTABLE INFUSION PUMP
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.; 500 international drive; suite 200; mount olive NJ 07828
• MDR Report Key: 9384839
• MDR Text Key: 168283489
• Report Number: 3010079947-2019-00130
• Device Sequence Number: 1
• Product Code: LKK
• 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: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2020
• Device Model Number: 91827
• Device Catalogue Number: 91827
• Device Lot Number: 25541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention