BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT

    MDR report key: 5013918 · Received August 19, 2015

    Report

    Report Number
    5013918
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Date of Event
    April 10, 2015
    Report Date
    July 22, 2015
    Manufacturer
    BELMONT INSTRUMENT CORP.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT NEEDED THE BELMONT FOR RAPID TRANSFUSION OF BLOOD PRODUCTS. THE CANISTER WAS PRIMED WITH 250ML NORMAL SALINE (NS) THEN ADDED FRESH FROZEN PLASMA (FFP) AND PACKED RED BLOOD CELLS (PRBCS), AND TRANSFUSED INTO THE PATIENT AT RATE OF 500 ML/MIN (PATIENT WAS HYPOVOLEMIC FROM OPERATIVE BLEEDING, BLOOD PRESSURE (BP) APPROXIMATELY 85 SYSTOLIC). AFTER ABOUT A MINUTE OR TWO, THE PATIENT DEVELOPED PROFOUND HYPOTENSION TO BP SYSTOLIC 40'S WITH TACHYCARDIA 130. THE BELMONT COULD NOT BE STOPPED AS THE PATIENT WAS BLEEDING RAPIDLY AND NEEDED THE BLOOD PRODUCTS. THE PATIENT WAS MEDICALLY MANAGED WITH PRESSORS; HYPOTENSION EVENTUALLY RESOLVED. WHEN GOING TO CHANGE TO A NEW BELMONT AFTER 4 HOURS, (THE PATIENT WAS STABLE WITH MORE CONTROLLED BLEEDING AND BP 140 SYSTOLIC), THE PATIENT AGAIN HAD A PROFOUNDLY HYPOTENSIVE (TO 40S SYSTOLIC) EPISODE WITH BOLUS RATE. THIS WAS THE FIRST EPISODE WE HAVE SEEN WITH REFRACTORY HYPOTENSION DURING BOLUSING OF BLOOD PRODUCTS THROUGH THE BELMONT. WE HAVE SINCE SEEN 4 OTHER INSTANCES THIS DURING SURGERIES INVOLVING LARGE BLOOD LOSSES OR HEMORRHAGE DUE TO INJURY. A FEW MONTHS BEFORE WE NOTICED THIS PHENOMENON, THE BELMONT COMPANY REDESIGNED THE LARGE RESERVOIR DISPOSABLE SYSTEM USED TO ADMINISTER BLOOD PRODUCTS AND FLUIDS. AFTER REVIEWING THE PATIENTS INVOLVED, 4 OF THE 5 WERE RECEIVING ACEI (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) MEDS PRE-OP. WE MET WITH THE BELMONT REP AND ENGINEERS AND HAVE CONVEYED OUR CONCERNS THAT THIS MIGHT BE A BRADYKININ RELATED REACTION WITH THE NEWLY RE-DESIGNED FILTERS THAT APPEARS TO ONLY MAINLY WITH PATIENTS ON ACEI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547540 THE BELMONT INFUSION PUMP FRN BELMONT INSTRUMENT CORP. 2015-0401

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR THIS CONCERN OCCURRED DURING RAPID TRANSFUSION OF