BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER

    MDR report key: 10833631 · Received November 12, 2020

    Report

    Report Number
    1219702-2020-00101
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    October 13, 2020
    Report Date
    November 12, 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 3-SPIKE DISPOSABLE SET INVOLVED IN THE INCIDENT WAS NOT AVAILABLE FOR INVESTIGATION. PHOTOGRAPHS PROVIDED BY THE USER FACILITY INDICATE EVIDENCE OF HIGH TEMPERATURE DAMAGE DUE TO BLOOD CLOTTING IN THE HEAT EXCHANGER OF THE DISPOSABLE SET; HOWEVER, WITHOUT INVESTIGATING THE SET A ROOT CAUSE CANNOT BE DETERMINED. THE ONLY KNOWN CAUSE OF COAGULATION IN CITRATED BLOOD IS THE ADDITION OF CALCIUM-CONTAINING PRODUCTS; THESE PRODUCTS ARE CONTRAINDICATED AS THEY MAY LEAD TO CLOT FORMATION INSIDE THE HEAT EXCHANGER, WHICH CAN BLOCK BLOOD FLOW AND RESULT IN AN OVER TEMPERATURE ISSUE. WHEN THE RAPID INFUSER DETECTS A SITUATION THAT IS COMPROMISING SAFE AND 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. 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 REPORTS 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. IT WAS REPORTED THAT THE DISPOSABLE SET WAS REPLACED; NO PATIENT INJURY WAS REPORTED. 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 THAT A RAPID INFUSER, RI-2 EXHIBITED AN "OVER TEMPERATURE" ALARM AFTER INFUSING 4 UNITS OF PACKED RED BLOOD CELLS AND SALINE. THE 3-SPIKE DISPOSABLE SET WAS REPLACED AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295779 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