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 Nausea (1970); Sleep Dysfunction (2517)

Event Date 06/08/2022

Event Type  Injury  

Event Description

Technical solutions received information regarding a potential pocket fill and subsequent pump replacement.Initially, the patient was seen for a normal refill appointment and no medication or dose changes were made.The patient reportedly called the physicians office the following morning to report that after the appointment they felt like they had "gotten 3 boluses at once".The patient also reported feeling nauseous, craving sugar, and not being able to stay awake.The day after the patient called the office, the patient returned to the office and a volume discrepancy was observed.The physician expected 19.3ml and only received 17ml back from the pump.The patient's pump was filled with new medication and the patient was monitored for a reaction.No reaction occurred initially, but the patient called three days later to report that they had begun feeling the same symptoms a couple of hours after most recent refill.The patient was then seen again at the office, where their pump was filled with saline.When the pump was filled, no volume discrepancy was observed.The patient's pump was later replaced.

Manufacturer Narrative

Pending completion of device analysis.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.Internal complaint number: (b)(4).

Manufacturer Narrative

Corrected information: h3, h6 device was returned for additional evaluation and investigation.Additional physical investigation was performed on the device, but the alleged issue could not be confirmed.Visual inspection of the pump showed that the unit was missing the tip at the end of the cannula and was replaced with a known working part.Operation of the pump reservoir function was checked by filling the reservoir with 20 ml of sterile water for injection (swi) and allowing the reservoir's pressure to return the fluid into the syringe.The reservoir was refilled and the cap was flushed with 5 ml of swi.A demand bolus of 0.300 mg with a 1.00 mg/ml concentration over 16 minutes was programmed with a programmer.The pump was able to prime at ambient temperature, but not at 37°c.The pump was programmed with a 1.994 mg daily dose multi-rate flow test over a 24-hour time period at 37°c for 1 day.The unit did not dispense any fluid during the 24- hours.This does not meet the design specification.Functional testing showed that the device primed, but did not flow when it was run overnight during the analysis.As the alleged issue of overinfusion was not observed, and instead the opposite was observed, the allegation was not confirmed.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
• 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: 15086931
• MDR Text Key: 296417308
• Report Number: 3010079947-2022-00136
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)160323(10)20903
• 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,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2016
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 20903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2015
• 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): Required Intervention
• Patient Sex: Male