BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELMONT RAPID INFUSER

    MDR report key: 2088211 · Received May 3, 2011

    Report

    Report Number
    2088211
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 23, 2011
    Report Date
    May 3, 2011
    Manufacturer
    BELMONT
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    AFTER APPROXIMATELY 3 HOURS OF USE DURING AN ORTHOTOPIC LIVER TRANSPLANT (OLT), AFTER 21 UNITS OF FFP AND 9 UNITS OF PACKED RED BLOOD CELLS (PRBCS), THE BELMONT UNIT ALARMED FOR OVERHEATING. THE UNIT WAS REMOVED FROM THE PATIENT. A SAMPLE FROM THE DISTAL END OF THE INFUSION LINE WAS TESTED FOR CALCIUM AND THE RESULT WAS TOO LOW TO MEASURE. THE BELMONT WAS INFUSING THROUGHOUT THE ENTIRE CASE THROUGH A DEDICATED LEFT INTERNAL JUGULAR CORDIS. NO DRUGS OR ANY INJECTIONS WERE DELIVERED THROUGH THE LINE. THE BELMONT WAS PRIMED WITH 500 ML OF NORMAL SALINE (NS) ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BELMONT RAPID INFUSER INFUSION PUMP FRN BELMONT * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *