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 Loss of consciousness (2418)

Event Date 05/15/2023

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 a patient was admitted to the er with a loss of consciousness following a refill appointment by their nurse.The doctor contacted technical solutions looking for a representative to inquire the pump to see if it was malfunctioning.Technical solutions asked for more information and the doctor reported that the patient was brought into the er by first responders shortly after a refill appointment for intrathecal fentanyl.It was reported that the patient was administered narcan prior to regaining consciousness.Technical solutions informed the physician that these symptoms were aligned with a pocket fill due to the sudden onset of symptoms.They asked technical solutions for next steps and technical solutions explained how to drain the pump to suspend further therapy.Technical solutions asked the physician to note and share the volume of medication removed from the pump.Technical solution then sent the physician an email with the refill procedure and other pertinent information.Technical solutions mentioned that they would be available via phone call as needed to assist on the draining.Later, an agent covering the issue contacted technical solutions regarding this issue.The agent reported that the managing physician was wondering how the pocket fill could have occurred since the nurse performing the refill had told them that they had felt the pressure when accessing the pump.Technical solutions mentioned that the refill ifu states that 1-2ml should be delivered, medication should be allowed to flow back, 5ml should be delivered, medication should be allowed to flow back, and this process should continue as long as the medication is flowing back.If the needle leaves the reservoir and the procedure is not followed, this could lead to a pocket fill as there was no confirmation the needle stayed in the pump.The agent relayed this to the physician who mentioned that the nurse was able to withdraw an unknown amount of medication from the pocket after the patient began decompensating and a "bubble" was seen above the pump, showing that a pocket fill, or a partial pocket fill, had occurred.Finally, a different physician contacted technical solutions regarding this issue.The physician initially reported that the team working on the patient wanted to decrease the patient's dosage using a programmer at the hospital.However, after looking at the patient's file, they did not wish to proceed with this as the patient is managed by a physician out of network.The physician reported that the patient is stable and doing well, which furthered their belief that changing the patient's dosage was not necessary at this time.Technical solutions let the physician know to call back if anything changes and they need technical assistance to decrease the dosing.

• 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: 16946046
• MDR Text Key: 315381253
• Report Number: 3010079947-2023-00042
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)210218(10)26323
• 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: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2021
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 26323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2020
• 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): Required Intervention; Hospitalization
• Patient Sex: Male