BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWONIX PROMETRA II

    MDR report key: 17005048 · Received May 24, 2023

    Report

    Report Number
    MW5117872
    Event Type
    Injury
    Date Received
    May 24, 2023
    Date of Event
    April 25, 2023
    Report Date
    May 22, 2023
    Manufacturer
    FLOWONIX MEDICAL INC.
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT HAD A FLOWONIX INTRATHECAL PAIN PUMP THAT WAS PLACED ON (B)(6) 2017. IT IS A FLOWONIX PROMETRA II 20 ML PUMP SERIAL NUMBER (B)(46. THIS PUMP HAD INTRATHECAL HYDROMORPHONE 15 MG/ML AND INTRATHECAL BACLOFEN 500 MCG/ML RUNNING AT 3.6 MG/DAY OF HYDROMORPHONE AND 120 MCG/DAY OF BACLOFEN. THIS PATIENT HAD SUDDEN ONSET OF WITHDRAWAL SYMPTOMS ON (B)(6) 2023 INCLUDING INCREASED PAIN, ANXIETY, YAWNING, DIARRHEA, DRY MOUTH AND PALPITATIONS. HE PRESENTED TO THE (B)(6) EMERGENCY ROOM ON (B)(6) 2023 WITH WORSENING SYMPTOMS. HE WAS DIAGNOSED WITH ACUTE WITHDRAWAL SYMPTOMS AND GIVEN ORAL DILAUDID AND BACLOFEN. THE PATIENT PRESENTED TO THE PAIN CLINIC ON (B)(6) 2023 WHERE HE WAS STILL EXHIBITING WITHDRAWAL SYMPTOMS OF ANXIETY, DIARRHEA, PAIN, PALPITATIONS, NAUSEA AND DEHYDRATION. I DID A CATHETER DYE STUDY AND FOUND THE CATHETER TO BE PATENT AND IN PROPER POSITION IN THE INTRATHECAL SPACE. WE ALSO INTERROGATED THE PUMP WITH NO ERRORS REPORTED. BASED ON THE PATIENT'S WORSENING WITHDRAWAL SYMPTOMS IT WAS DECIDED TO TURN THE PUMP OFF AND MANAGE THE SYMPTOMS WITH ORAL MEDICATIONS AND REPLACE THE PUMP BECAUSE OF SUSPECTED MALFUNCTION. THE PATIENT PRESENTED FOR SURGERY ON (B)(6) 2023 AFTER SEVERAL ER VISITS AND ADJUSTMENTS OF HIS ORAL MEDICATION TO KEEP WITHDRAWAL SYMPTOMS UNDER CONTROL. SINCE THERE WAS NO FLOWONIX PRODUCTS AVAILABLE IT WAS DECIDED TO REPLACE WITH A MEDTRONIC PUMP. AS THE FLOWONIX CATHETER IS NOT COMPATIBLE WITH THE MEDTRONIC PUMP THE PATIENT ALSO HAD TO UNDERGO REPLACEMENT OF HIS CATHETER IN ADDITION TO THE PUMP REPLACEMENT. PATIENT UNDERWENT A SUCCESSFUL REPLACEMENT OF HIS PUMP AND CATHETER WITH A MEDTRONIC SYSTEM AND THE FLOWONIX PUMP WAS SENT TO FLOWONIX MEDICAL FOR ANALYSIS. THIS PUMP WAS SENT FOR SUSPICION OF PREMATURE BATTERY FAILURE. THE PUMP WAS SENT TO: RETURN PRODUCT ANALYSIS FLOWONIX MEDICAL, INC. 120 FORBES BLVD., SUITE 170 MANSFIELD, MA 02048 SENT VIA FEDEX TRACKING NUMBER (B)(4) FLOWONIX RECENTLY SENT OUT A "URGENT MEDICAL DEVICE CORRECTION UPDATE" DATED (B)(6) 2023, OUTLINING PREMATURE FAILURE OF THE FLOWONIX PUMP PARTICULARLY THOSE MANUFACTURED AFTER 2020. EVEN THOUGH THIS PUMP WAS MANUFACTURED PRIOR TO 2020, WE SUSPECT IT HAD A PREMATURE FAILURE THAT CAUSED HARM TO THE PATIENT, WHICH IS WHY I AM REPORTING THIS INCIDENT AND REQUESTING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1576576 FLOWONIX PROMETRA II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK FLOWONIX MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention| H| O BACLOFEN 500 MCG/ML.| HYDROMORPHONE 15 MG/ML.