BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER

    MDR report key: 11103318 · Received December 31, 2020

    Report

    Report Number
    1219702-2020-00127
    Event Type
    Malfunction
    Date Received
    December 31, 2020
    Date of Event
    November 9, 2020
    Report Date
    December 31, 2020
    Manufacturer
    BELMONT MEDICAL TECHNOLOGIES
    Product Code
    LGZ
    UDI-DI
    00896128002022
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPOSABLE SET HAS BEEN RETURNED TO BELMONT FOR INVESTIGATION AND EVALUATION IS IN PROCESS. WHEN THE RAPID INFUSER DETECTS A SITUATION THAT IS COMPROMISING EFFECTIVE INFUSING, THE SYSTEM STOPS PUMPING AND HEATING, CLOSES OFF THE LINE TO THE PATIENT, SOUNDS AN AUDIBLE ALARM, AND DISPLAYS AN ALARM MESSAGE WITH INSTRUCTIONS FOR CORRECTIVE MEASURE. THERE IS NOT ENOUGH INFORMATION AVAILABLE AT THIS TIME TO DRAW A CONCLUSION ABOUT THE ROOT CAUSE OF THE REPORTED BURNING ODOR. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT. THE MANUFACTURING BATCH RECORDS FOR THIS LOT WERE REVIEWED AND NO RELATED ANOMALIES WERE IDENTIFIED. A REVIEW OF PAST COMPLAINTS INDICATES THAT THERE HAVE BEEN NO OTHER COMPLAINTS RELATED TO THIS LOT NUMBER. ALL 3-SPIKE DISPOSABLE SETS ARE 100% LEAK TESTED AND 100% VISUALLY INSPECTED PRIOR TO RELEASE FROM BELMONT MEDICAL TECHNOLOGIES. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    BELMONT'S DISTRIBUTOR RECEIVED A REPORT FROM THE USER FACILITY THAT A BURNING ODOR WAS NOTED 1-2 MINUTES AFTER INFUSING OF PRBCS AND WARMED PLASMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564767 THE BELMONT RAPID INFUSER THERMAL INFUSION FLUID WARMER LGZ BELMONT MEDICAL TECHNOLOGIES 3-SPIKE DISPOSABLE SET 2020-01 14 00896128002022

    Patients

    Seq Age Sex Outcome Treatment
    1