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

Model Number 13827

Device Problem Use of Device Problem (1670)

Patient Problem Muscular Rigidity (1968)

Event Date 05/16/2023

Event Type  Injury  

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 remains implanted and was not returned for additional evaluation and investigation.The issue was determined to be the result of user error during the refill process.Per the instructions for use of the device, refill errors are known possible risks of use of the device.Internal complaint number: (b)(4).

Event Description

Physician contacted technical solutions after their patient had been in the icu overnight after a refill appointment.Physician reported that their staff member had performed a refill the day prior and everything appeared well.However, shortly after programming the refill, it was reported that the patient began decompensating rapidly.Physician reported that the patient had symptoms of a fentanyl overdose, including chest rigidity.Narcan had to be administered by the physician's team before emts arrived on scene.Physician stated that they accessed the pocket and were able to pull roughly 8ml of medication.The pump was noted to contain 10ml.The physician removed the medication and pushed in 10cc of pf saline to determine if the pump was functional.They aspirated all 10cc after two saline flushes.Physician put the medication back into the pump but shut the pump off prior to the patient being taken to the hospital.The physician reported that after determining it was a pocket fill, they would be going to the hospital to turn the pump back on to prevent withdrawal.Later communication with an office representative confirmed that the patient had been discharged from the hospital and was doing well.The representative also confirmed that the patient had resumed their therapy.

• 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
• Manufacturer (Section G): FLOWONIX MEDICAL, INC.; 120 forbes blvd; suite 170; mansfield MA 02048
• Manufacturer Contact: james bennett ; 500 international drive; suite 200; mount olive, NJ 07828 ; 9734269229
• MDR Report Key: 17010084
• MDR Text Key: 316012611
• Report Number: 3010079947-2023-00044
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)191117(10)23579
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2019
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 23579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female