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 Abdominal Pain (1685); Unspecified Gastrointestinal Problem (4491)

Event Date 12/17/2021

Event Type  Death  

Event Description

Agent contacted technical solutions to report that a patient had passed away.Agent reported that the patient had an mri on both knees last year, and at the time of the mri, no volume discrepancy was noted.Medications were 25milligrams/ml of morphine (6 milligrams per day), 250micrograms/ml of fentanyl (60 micrograms per day), and 7.5micrograms/ml of prialt (2.4 micrograms per day).A few days after the mri, the patient reportedly contacted the physician's office complaining of abdominal and gi pain.The patient was informed that if the pain continued, they should go to the er.Patient went to the er and had a ct on their abdomen at that time.Patient then came to the physician's office a few days later for a refill.During initial report to agent, an underinfusion was reported (4ml expected, 15ml returned), but this was later clarified as an overinfusion (4 ml expected volume, 0 ml returned).During this refill, a medication change was made from 7.5 microgram/ml prialt to 10 microgram prialt/ml (concentration change not daily dose).Refill documentation has been requested and not received.Patient reportedly passed away days later.Device return and autopsy results have been requested for investigation purposes.

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 not returned.As the device was not returned for additional evaluation and investigation, a definitive root cause could not be determined for the alleged issue.Agent is following up with the coroner's office.Supplemental mdr will be submitted if/when additional information is received.(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
• 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: 13803323
• MDR Text Key: 287385882
• Report Number: 3010079947-2022-00044
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)210827(10)26819
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2021
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 26819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2020
• 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): Death; Hospitalization; Other