BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 16600179 · Received March 23, 2023

    Report

    Report Number
    3016798778-2023-00011
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Date of Event
    February 19, 2023
    Report Date
    August 22, 2023
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    PMA / PMN Number
    K202690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) IS THE SERIAL NUMBER ENTERED IN D4 OF THIS REPORT. (B)(6) IS THE SERIAL NUMBER OF THE DISTRIBUTED KIT WHICH CONTAINED PUMP SERIAL NUMBER (B)(6), FOUND TO BE IN USE AT THE TIME OF THE REPORTED EVENT, BASED ON REPORTED INFORMATION, KITS (B)(6) WERE RECORDED ON THE INITIAL MANUFACTURER'S REPORT, BUT NOT INCLUDED ON THIS REPORT AS NO ASSOCIATED DEVICES FROM THOSE KITS WERE IN USE AT THE TIME OF THE REPORTED EVENT.

    Description of Event or Problem · 0

    A REPORT OF A PATIENT DEATH ON (B)(6) 2023 WAS RECEIVED BY UNITED THERAPEUTICS ON (B)(6)2023 AND FORWARDED THE SAME DAY TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC. THE HOSPITAL REPORTED THAT THE DEATH WAS RELATED TO THE PROGRESSION OF UNDERLYING DISEASE AND WAS NOT CAUSALLY RELATED TO REMODULIN THERAPY. THE PATIENT HAD TWO PRIOR ADMISSIONS FOR REMUNITY PUMP FAILURE AND MALFUNCTIONS. BOTH HAVE BEEN PREVIOUSLY REPORTED (3016798778-2023-00005. ADDITIONAL INFORMATION FROM THE CLINICIAN INDICATED THAT "THESE MULTIPLE HOSPITALIZATIONS WITH TREPROSTINIL INTERRUPTIONS DUE TO PUMP FAILURE MAY HAVE CONTRIBUTED TO HER WORSENING."

    Description of Event or Problem · 0

    AN INITIAL MDR REGARDING THIS CASE WAS FILED 23-MAR-2023 (REPORT NUMBER 3016798778-2023-00011). ADDITIONAL INFORMATION WAS RECEIVED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC BY WAY OF A COMPLETED TECHNICAL INVESTIGATION ON RECENTLY RECEIVED MATERIALS THAT WERE IN USE BY THE PATIENT DURING THE REFERENCED EVENT. LOGS FROM RETURNED PUMP (SERIAL NUMBER (B)(6)) INDICATED THAT ON 19-FEB-2023, THE USER RECEIVED AN OCCLUSION ALARM 25 MINUTES INTO TREATMENT. LOGS LEADING UP TO THIS ALARM ARE CONSISTENT WITH A REAL OCCLUSION. DETECTION OF OCCLUSIONS IN THE FLUID PATH DURING REMODULIN DELIVERY IS AN ESSENTIAL PERFORMANCE OF THE DESIGN OF THE PUMP. AN OCCLUSION ALARM OCCURS WHEN THE TUBING OR CATHETER IS BLOCKED OR PARTIALLY BLOCKED FROM DELIVERING MEDICATION. UPON RECEIVING AN OCCLUSION ALARM, THE USER IS INSTRUCTED TO DISCONNECT THE INFUSION SET TUBING FROM THE CATHETER AND CHECK THE INFUSION SET TUBING FOR KINKS. UPON RESOLVING THE ALARM, THE USER IS FURTHER INSTRUCTED TO ROUTE THE INFUSION SET TUBING TO AVOID ANY SOURCES OF KINKS THAT MIGHT HAVE INTRODUCED THE OCCLUSION THAT TRIGGERED THE ALARM. THE PUMP PERFORMED AS EXPECTED DURING INVESTIGATION. SINCE NO CASSETTES OR INFUSION SETS WERE RETURNED, THE CAUSE OF THE OCCLUSION ALARM COULD NOT BE DETERMINED. ALL OTHER RETURNED DEVICES WERE EITHER NEVER USED OR WERE USED AFTER THE EVENT. NO ISSUES WERE IDENTIFIED WITH THE RETURNED PRODUCTS; ALL PERFORMED AS DESIGNED DURING TESTING. NO FURTHER INVESTIGATION IS POSSIBLE.

    Description of Event or Problem · 0

    AN INITIAL REPORT OF PATIENT HOSPITALIZATION WAS RECEIVED BY UNITED THERAPEUTICS ON 21-FEB-2023 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 22-FEB-2023. THE PATIENT REPORTED THEY COULD NOT RESUME DELIVERY WITH MAIN OR BACK-UP PUMPS AS THE REMOTES REPEATEDLY DISPLAYED A MESSAGE TO CHANGE THE CASSETTE. TROUBLESHOOTING WAS UNSUCCESSFUL, SO THE PATIENT WENT TO THE HOSPITAL TO CONTINUE RECEIVING REMODULIN THERAPY. NO COMPONENTS OR ADDITIONAL INFORMATION ASSOCIATED WITH THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER FOR FURTHER EVALUATION DESPITE MULTIPLE REQUESTS. DESPITE NO REPORT OF DEATH OR SERIOUS INJURY, THIS ISSUE IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444483 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Other| H