BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER

    MDR report key: 5098666 · Received September 23, 2015

    Report

    Report Number
    1219702-2015-00001
    Event Type
    Malfunction
    Date Received
    September 23, 2015
    Date of Event
    April 10, 2015
    Report Date
    September 23, 2015
    Manufacturer
    BELMONT INSTRUMENT CORPORATION
    Product Code
    LGZ
    UDI-DI
    00896128002008
    PMA / PMN Number
    K091855
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BELMONT IMMEDIATELY RESPONDED TO THE REPORT OF THIS INCIDENT BY MEETING WITH THE FACILITY IN ORDER TO UNDERSTAND THE NATURE OF THE EVENT. THE TEAM AT THE FACILITY FIRST EXPLAINED THAT THEY HAD A NUMBER OF EVENTS IN WHICH THERE WAS A MARKED DROP IN BLOOD PRESSURE WHILE RAPIDLY INFUSING INTO A PATIENT. THE POSSIBILITY THAT BRADYKININS WERE BEING GENERATED BY A VISUAL CHANGE TO THE FILTER SUPPORT WAS RAISED. BELMONT EXPLAINED THAT WHILE THE FILTER DID INDEED LOOK DIFFERENT, THE MATERIALS WERE ALL THE VERY SAME CLASS VI MATERIALS THAT HAD BEEN UTILIZED IN THE SYSTEM SINCE ITS INITIAL RELEASE IN 1997; THE CHANGE WAS SIMPLY OF GEOMETRY AND THE FILTER MATERIAL WAS EXACTLY THE SAME AS IT HAS ALWAYS BEEN. BELMONT CONTRACTED WITH AN INDEPENDENT LABORATORY TO RUN SPECIFIC TESTS IN ORDER TO DETERMINE WHETHER OUR SYSTEM COULD CAUSE THE GENERATION OF BRADYKININS. THE TEST RESULTS REVEALED THAT THERE IS NO GREATER GENERATION OF BRADYKININS WITH THE NEW RESERVOIR COMPARED WITH THE OLD RESERVOIR. THE BOLUS FEATURE IS A TEMPORARY INCREASE IN FLOW RATE FOR A SPECIFIC VOLUME. THE SIGNIFICANCE OF THIS IS THAT ALL OF THE EVENTS APPEAR WHEN THERE IS A HIGH RATE OF INFUSION, SUGGESTING THAT THE KEY IS THE INFUSATE. SINGLE-USE DISPOSABLE DEVICE.

    Description of Event or Problem · 1

    THE REPORT FROM THE USER FACILITY DESCRIBES AN EVENT IN WHICH SALINE AND A NUMBER OF BLOOD PRODUCTS WERE BEING INTRODUCED INTO A PATIENT IN RESPONSE TO SURGERY-INDUCED HYPOVOLEMIA AT A RATE OF 500 ML/MIN. AFTER 500 TO 1000 ML OF PRODUCTS WERE INFUSED, THE PATIENT BEGAN TO EXPERIENCE TACHYCARDIA AND A DROP IN BLOOD PRESSURE, WHICH WERE MANAGED WITH PRESSORS. THE SYSTEM WAS PROPHYLACTICALLY REPLACED AND A SIMILAR EVENT OCCURRED SUBSEQUENTLY 4 HOURS LATER DURING A BOLUS OPERATION OF THE REPLACEMENT SYSTEM. THIS WAS THE FIRST INCIDENT WHERE A BOLUSING OF BLOOD PRODUCTS WAS NOTICED TO CAUSE A HYPOTENSIVE EVENT. FOLLOWING THIS EVENT, THERE WERE 4 SIMILAR CASES. IT WAS NOTED THAT OF THE 5 CASES, A TOTAL OF 4 PATIENTS WERE RECEIVING ACE INHIBITORS. IT WAS ALSO NOTED THAT THE RESERVOIR FILTER ASSEMBLY HAD BEEN REDESIGNED THE PREVIOUS YEAR. BELMONT ENGINEERING RESPONDED TO THE INITIAL INQUIRY BY MEETING WITH THE HOSPITAL PERSONNEL IN ORDER TO UNDERSTAND THE SITUATION. THE HOSPITAL PERSONNEL SPECULATED THAT THE CHANGE IN THE FILTER MIGHT BE CAUSING THE GENERATION OF BRADYKININS IN THE BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629682 THE BELMONT RAPID INFUSER THERMAL INFUSION FLUID WARMER LGZ BELMONT INSTRUMENT CORPORATION FMS2000 2015-04 01 00896128002008

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other