BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER

    MDR report key: 10806418 · Received November 8, 2020

    Report

    Report Number
    1219702-2020-00096
    Event Type
    Malfunction
    Date Received
    November 8, 2020
    Date of Event
    October 5, 2020
    Report Date
    November 8, 2020
    Manufacturer
    BELMONT MEDICAL TECHNOLOGIES
    Product Code
    LGZ
    UDI-DI
    00896128002022
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE 3-SPIKE DISPOSABLE SET INVOLVED IN THE INCIDENT WAS NOT AVAILABLE FOR INVESTIGATION. WITHOUT EVALUATING THE SET, THE ROOT CAUSE OF THE REPORTED LEAK CANNOT BE DETERMINED. THE MANUFACTURING BATCH RECORDS FOR THIS LOT WERE REVIEWED AND NO RELATED ANOMALIES WERE IDENTIFIED. ALL 3-SPIKE DISPOSABLE SETS ARE 100% LEAK TESTED AND 100% VISUALLY INSPECTED PRIOR TO RELEASE FROM BELMONT MEDICAL TECHNOLOGIES. A REVIEW OF PAST COMPLAINTS INDICATES THAT THERE HAVE BEEN NO OTHER COMPLAINTS RELATED TO THIS LOT NUMBER. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT. BELMONT WILL CONTINUE TO MONITOR AND TREND SIMILAR REPORTS OF THIS NATURE AND TAKE FURTHER ACTION IF REQUIRED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    BELMONT'S DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY AND REPORTED THE FOLLOWING: "THE RAPID INFUSER 3-SPIKES DISPOSABLE SET WAS LEAKING AT THE TOP OF PRESSURE CHAMBER DURING NORMAL USAGE. THE DISPOSABLE SET WAS REPLACED WITH A NEW ONE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271198 THE BELMONT RAPID INFUSER THERMAL INFUSION FLUID WARMER LGZ BELMONT MEDICAL TECHNOLOGIES 3-SPIKE DISPOSABLE SET 2020-04 10 00896128002022

    Patients

    Seq Age Sex Outcome Treatment
    1