BEUDAMED
    FDA Adverse Event Death Summary report: N

    BELMONT RAPID INFUSER

    MDR report key: 6959372 · Received October 18, 2017

    Report

    Report Number
    1219702-2017-00001
    Event Type
    Death
    Date Received
    October 18, 2017
    Date of Event
    January 29, 2017
    Report Date
    October 18, 2017
    Manufacturer
    BELMONT INSTRUMENT CORPORATION
    Product Code
    LGZ
    UDI-DI
    10896128002012
    PMA / PMN Number
    K091855
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ON FEBRUARY 22, 2017, WE RECEIVED MEDWATCH UF/IMPORTER REPORT (B)(4), REGARDING AN INCIDENT THAT OCCURRED ON (B)(6) 2017. ONE OF THE IMPLICATED RAPID INFUSERS, S/N (B)(4), WAS RETURNED FOR EVALUATION ON FEBRUARY 28, 2017. THE DEVICE WAS TESTED USING OUR STANDARD OPERATING PROCEDURES; HOWEVER, WE WERE UNABLE TO CONFIRM THE COMPLAINT. THE UNIT PERFORMED ACCORDING TO OUR SPECIFICATIONS UPON RECEIPT. THE OTHER IMPLICATED RAPID INFUSER S/N (B)(4), MANUFACTURED IN FEBRUARY 2015, WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PATIENT WENT INTO SURGERY FOR A LIVER TRANSPLANT AT 10 PM ON (B)(6) 2017. AS PART OF THIS PROCEDURE, THE HOSPITAL STAFF USED A BELMONT RAPID INFUSER TO TRANSFUSE BLOOD. (INFUSER 1) THE INFUSER WAS PLUGGED INTO A POWER STRIP. IT WAS NOT PLUGGED DIRECTLY INTO "A GROUNDED, 3-PRONG, 20 AMP, AC RECEPTACLE", AS REQUIRED BY THE DEVICE'S INSTRUCTIONS FOR USE. ACCORDING TO THE HOSPITAL, AT APPROXIMATELY 12 AM, THE PATIENT REPORTEDLY BEGAN LOSING PRESSURE AND BLEEDING. IN RESPONSE, THE HOSPITAL STAFF INCREASED THE TRANSFUSION RATE TO 500 ML (INFUSER 1). AT 1:07 AM THE PATIENT WENT INTO CARDIAC ARREST. AT THE SAME TIME, THE POWER IN THE OPERATING ROOM TRIPPED AND THE RAPID INFUSER WENT INTO BATTERY MODE, DROPPING THE INFUSION RATE TO 50 ML. THE OPERATING ROOM STAFF ATTEMPTED TO SWITCH THE INFUSER WITH ANOTHER BELMONT RAPID INFUSER (INFUSER 2), BUT THE SECOND INFUSER DID NOT POWER UP, INDICATING THAT THE HOSPITAL AC POWER WAS NOT PRESENT. THE HOSPITAL OBTAINED A THIRD BELMONT RAPID INFUSER (INFUSER 3), WHICH DID POWER UP WITH AC-POWER, BUT THE DEVICE WAS NO LONGER NEEDED AS THE PATIENT WAS DECLARED DEAD AT 1:25 AM. THE SERIAL NUMBERS FOR BOTH INFUSERS 1 AND 2 ARE INCLUDED IN THIS FORM. THE HOSPITAL COULD NOT IDENTIFY WHICH OF THE UNITS WAS USED FIRST, BUT THE SITE DID PROVIDE SERIAL NUMBERS FOR BOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737483 BELMONT RAPID INFUSER THERMAL INFUSION FLUID WARMER LGZ BELMONT INSTRUMENT CORPORATION FMS 2000 10896128002012

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death