BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID INFUSER RI-2

    MDR report key: 12048643 · Received June 23, 2021

    Report

    Report Number
    12048643
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    June 17, 2021
    Report Date
    June 17, 2021
    Manufacturer
    BELMONT INSTRUMENT CORPORATION
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INITIATED MASSIVE TRANSFUSION USING BELMONT RAPID INFUSER RI-2 TO A TRAUMA PATIENT. NOTED BLOOD LEAKING OUT OF SIDE OF THE RAPID INFUSER MACHINE AND WHEN THE DOOR OF RAPID INFUSER WAS OPENED, BLOOD WAS SEEN TO BE LEAKING AT A CONNECTION NEAR THE CIRCLE. IT WAS NOTED THAT THE TUBING WAS CORRECTLY LOADED. OBTAINED SECOND SET OF TUBING WHICH WAS LOADED INTO A DIFFERENT BELMONT RAPID INFUSER MACHINE AND PRIMED TUBING WITH SALINE. WHEN STARTING TO INFUSE BLOOD, TEAM MEMBER NOTED SALINE TO BE LEAKING FROM SIDE OF RAPID INFUSER MACHINE AGAIN. TUBING WAS OBSERVED TO BE LEAKING AT THE SAME PLACE NEAR A CONNECTION BY THE CIRCLE AS THE FIRST SET OF TUBING. UNFORTUNATELY TEAM MEMBER WAS UNABLE TO GET THE PACKAGING FOR THE TUBING AS HOUSEKEEPING WAS VERY EFFICIENT AND HAD TAKEN THE GARBAGE WITH THE TUBING PACKAGE AWAY ALREADY. LOT NUMBER OF TUBING IN SAME CABINET IS 2021-0308. THANKFULLY PATIENT WAS STABLE AS THIS TIME AND DID DELAY CARE FOR APPROXIMATELY 10 MINUTES AS PATIENT DID NOT RECEIVE BLOOD DURING THE TIME OF PRIMING TUBING AND FINALLY NEEDING TO USE A REGULAR BLOOD TUBING WITH A PRESSURE BAG. ONE OF THE TWO DISPOSABLE TUBING WAS SAVED AND WE HAVE CONTACTED A REPRESENTATIVE OF THE COMPANY TO PICK UP THE TUBING AT OUR FACILITY. PHOTOS WERE TAKEN AND EMAILED TO THE COMPANY REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949573 RAPID INFUSER RI-2 WARMER, THERMAL, INFUSION FLUID LGZ BELMONT INSTRUMENT CORPORATION 2021-0308

    Patients

    Seq Age Sex Outcome Treatment
    1 25185 DA