BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 18131142 · Received November 14, 2023

    Report

    Report Number
    3016798778-2023-00068
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    October 18, 2023
    Report Date
    February 21, 2024
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    PMA / PMN Number
    K202690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AN INITIAL MDR REGARDING THIS CASE WAS FILED 14-NOV-2023 (REPORT NUMBER). 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 REMOTE UTRM0007685 (PAIRED WITH PUMP UTPM0010851) AND REMOTE UTRM0007686 (PAIRED WITH PUMP UTPM0010852) SHOW THAT ON THE DATE OF THE COMPLAINT, THE SYSTEMS GENERATED ALARMS. DURING INVESTIGATION ON BOTH SYSTEMS THE PUMPS WERE DISASSEMBLED FOR FURTHER INVESTIGATION, AND FLUID INGRESS WAS OBSERVED. FLUID INGRESS IS SUSPECTED TO BE THE CAUSE OF THE ALARMS THE PATIENT EXPERIENCED. NO CASSETTES WERE RETURNED, SO THE CAUSE OF THE FLUID INGRESS INTO THE PUMPS CANNOT BE CONFIRMED. NO FURTHER INVESTIGATION IS POSSIBLE. BOTH SYSTEMS WERE OBSERVED TO HAVE APPROPRIATELY ALARMED AND ENTERED A FAILSAFE STATE AS DESIGNED.

    Description of Event or Problem · 0

    AN INITIAL REPORT OF HOSPITALIZATION WAS RECEIVED BY UNITED THERAPEUTICS ON 19-OCT-2023 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 20-OCT-2023. THE PATIENT REPORTED HAVING A CASSETTE LEAK INTO HER PUMP, CAUSING IT TO FAIL. A BACKUP PUMP ALSO FAILED WITH A NEW CASSETTE. THE PATIENT THEN TRIED TO USE ADDITIONAL CASSETTES BUT HAD DIFFICULTY AND COULD NOT RESOLVE CASSETTE DEPLETED ALARMS ON TWO ADDITIONAL PUMPS. THE PATIENT REPORTED SHE WENT TO THE HOSPITAL ON (B)(6) 2023 TO RECEIVE REMODULIN AND WAS DISCHARGED THE SAME DAY WHEN ADDITIONAL SUPPLIES ARRIVED. A CLINICIAN FOLLOWED UP STATING THAT ADDITIONAL EDUCATION WAS PROVIDED TO THE PATIENT REGARDING PROPER CASSETTE PRIMING TECHNIQUE. THE CLINICIAN ALSO CONFIRMED THAT THE PATIENT WAS ASYMPTOMATIC WHEN SHE WENT TO THE HOSPITAL ON (B)(6) 2023 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
    1876111 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization ALENDRONATE SODIUM| ALENDRONATE SODIUM| ALEVE| ALEVE| AZELASTINE HCL| AZELASTINE HCL| CALCIUM| CALCIUM| DILTIAZEM| DILTIAZEM| KLOR-CON M20| KLOR-CON M20| LASIX| LASIX| LETAIRIS| LETAIRIS| MERCAPTOPURINE| MERCAPTOPURINE| OXYGEN| OXYGEN| PREDNISONE| PREDNISONE| SOD CHLORIDE| SOD CHLORIDE| SULFASALAZINE| SULFASALAZINE| VITAMIN D3| VITAMIN D3| ZOFRAN| ZOFRAN