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 Confusion/ Disorientation (2553)

Event Date 10/28/2021

Event Type  Injury  

Event Description

A clinician's office called to report that a patient had an episode of confusion immediately following a refill procedure.The representative reported that they refilled the patient with 20 ml of dilaudid (concentration was unknown).They reported that shortly after the patient began to experience severe confusion.They report that they checked the reservoir immediately and only got 15 ml of dilaudid back.The physician's assistant who performed the refill stated that they felt like they pushed in the last 5ccs quicker than usual, they felt the needle dislodged inside the pump and felt it was not correctly seated.They report that the patient was brought to the er immediately after.The patient was simply monitored at the er and released with no further complications.The representative reports that they used a medtronic refill kit.There are no plans for pump replacement as this was not believed to be a pump malfunction issue.

Manufacturer Narrative

Device was not returned.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.This issue was not believed to be related to pump malfunction, it was determined to be a pocket fill issue.Per the instructions for use of the device, refill errors including pocket fill are known possible risks of use of the device.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: 12869194
• MDR Text Key: 281206870
• Report Number: 3010079947-2021-00318
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)170720(10)22679
• 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: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2017
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 22679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2017
• 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; Other
• Patient Sex: Female