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

Model Number 13827

Device Problem Pumping Stopped (1503)

Patient Problems Incontinence (1928); Discomfort (2330); Inadequate Pain Relief (2388)

Event Date 03/30/2023

Event Type  malfunction  

Event Description

Reporter contacted technical solutions regarding a patient's pump that read error code 100 and 123 following the patient therapy controller (ptc) showing error code 34.The reporter also stated that the patient had attempted to press the rx button on the ptc "dozens of times" prior to inquiry of the pump.Patient reportedly experienced withdrawal symptoms, "extreme pain" and "incontinence." technical solutions walked the reporter through a soft reset of the pump, by programming a 0mg demand bolus over 2 minutes, which cleared the errors.Technical solutions explained to the reporter that the errors may return within 24 hours post soft reset and to have the patient immediately call their nurse or doctor if they began feeling withdrawal symptoms again.Technical solutions advised the reporter to have the patient wait for the new ptc to be set up in case the pump errors were related to the ptc.Technical solutions later contacted the reporter to see if the error codes had returned.The reporter stated that the patient had been able to successfully deliver themselves a bolus after connecting to the new ptc.It was also confirmed that the pump errors had not returned.

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.As additional physical investigation was not performed on the device, a definitive root cause could not be determined for the alleged issue.If additional information becomes available, a supplemental mdr will be sent.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: 16726524
• MDR Text Key: 313159132
• Report Number: 3010079947-2023-00029
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)190614(10)24930
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2019
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 24930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2018
• 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 Sex: Female