BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER

    MDR report key: 11572657 · Received March 25, 2021

    Report

    Report Number
    1219702-2021-00046
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Report Date
    March 25, 2021
    Manufacturer
    BELMONT MEDICAL TECHNOLOGIES
    Product Code
    LGZ
    UDI-DI
    10896128002760
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RAPID INFUSER, (B)(4) INVOLVED IN THE INCIDENT WAS RETURNED TO BELMONT FOR INVESTIGATION ON 3/12/2021. EVALUATION OF THE UNIT IS IN PROCESS. THE DISPOSABLE SET INVOLVED IN THE INCIDENT WAS NOT AVAILABLE FOR INVESTIGATION, NOR WAS THE USER FACILITY ABLE TO PROVIDE THE LOT NUMBER INVOLVED. FOLLOW UP WITH THE USER FACILITY REVEALED THAT THE INCIDENT OCCURRED SEVERAL MONTHS AGO AND THAT THERE HAVE BEEN NO ISSUES SINCE. REVIEW OF THE VIDEO PROVIDED BY THE USER FACILITY APPEARED TO INDICATE A SMALL LEAK FROM BELOW THE HEAT EXCHANGER OF THE DISPOSABLE SET, HOWEVER WITHOUT INVESTIGATING THE SET A ROOT CAUSE CANNOT BE ESTABLISHED. EVALUATION OF THE (B)(4) DEVICE WILL BE COMPLETED TO DETERMINE WHETHER THERE ARE ANY ANOMALIES WITH THE DEVICE. FURTHER INVESTIGATION IS ALSO BEING CONDUCTED TO DETERMINE WHICH LOT NUMBERS MAY HAVE BEEN INVOLVED IN THE INCIDENT. WITHOUT THE ABILITY TO INVESTIGATE THE DISPOSABLE SET OR ASSOCIATED LOT NUMBER, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE REPORTED PERFORATION IN THE TUBING. ALL DISPOSABLE SETS ARE 100% VISUALLY INSPECTED AND 100% LEAK-TESTED PRIOR TO RELEASE FROM BELMONT MEDICAL TECHNOLOGIES. THE MANUFACTURING RECORDS FOR THE (B)(4) SERIAL NUMBER WERE REVIEWED AND NO ANOMALIES WERE IDENTIFIED. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE PHYSICIAN AT THE USER FACILITY REPORTED THE FOLLOWING INVOLVING A BELMONT RAPID INFUSER, (B)(4): "WE USE YOUR RAPID INFUSERS IN ALL OUR CARDIAC CASES AND ANY OTHER CASES (TRAUMAS ETC.) WHERE WE ANTICIPATE LARGE-VOLUME RESUSCITATION. RECENTLY WE HAD A COUPLE OF INSTANCES DURING OPEN AORTIC CASES (WHERE WE WERE RUNNING IN UPWARDS OF 50 UNITS OF BLOOD PRODUCTS AT RATES > 200-300 ML/MIN FOR LENGTHY PERIODS) WHERE THE TUBING WITHIN THE HOUSING UNIT APPEARED TO HAVE PERFORATED. THIS REQUIRED HAVING TO REPLACE THE BELMONT MID-CASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468556 THE BELMONT RAPID INFUSER THERMAL INFUSION FLUID WARMER LGZ BELMONT MEDICAL TECHNOLOGIES RI-2 10896128002760

    Patients

    Seq Age Sex Outcome Treatment
    1