BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER

    MDR report key: 10681429 · Received October 14, 2020

    Report

    Report Number
    1219702-2020-00086
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    September 13, 2020
    Report Date
    October 14, 2020
    Manufacturer
    BELMONT MEDICAL TECHNOLOGIES
    Product Code
    LGZ
    UDI-DI
    00896128002008
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE 3.0 LITER RESERVOIR WAS DISCARDED AT THE HOSPITAL AND WAS THEREFORE NOT AVAILABLE FOR INVESTIGATION. IT WAS REPORTED THAT THERE WAS NO DAMAGE TO THE DISPOSABLE SET AS A RESULT OF THE REPORTED "OVER TEMPERATURE" INCIDENT. THE LIBRARY/RETAIN SAMPLE FOR THIS LOT WAS REVIEWED AND NO MANUFACTURING ISSUES WERE NOTED. THE MANUFACTURING BATCH RECORDS FOR THIS LOT WERE ALSO REVIEWED AND NO ANOMALIES WERE IDENTIFIED. ALL 3.0 LITER RESERVOIRS ARE 100% LEAK TESTED AND 100% VISUALLY INSPECTED PRIOR TO RELEASE FROM BELMONT MEDICAL TECHNOLOGIES. THE RAPID INFUSER, RI-2 INVOLVED IN THE INCIDENT WAS EVALUATED BY THE DISTRIBUTOR AND PERFORMED ACCORDING TO SPECIFICATION. WHEN THE RAPID INFUSER DETECTS A SITUATION THAT IS COMPROMISING EFFECTIVE INFUSION, 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. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT. WE 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 INVOLVING THREE DISPOSABLE PRODUCTS (3-SPIKE DISPOSABLE SET, 3.0 LITER RESERVOIR, AND DUAL PATIENT LINE) AND REPORTED THE FOLLOWING: "DURING 'TOTAL ABDOMINAL HYSTERECTOMY', #102 OVER TEMPERATURE ERROR OCCURRED USING RI-2. THE USER HAS REPLACED THE NEW DISPOSABLE KIT." THIS REPORT IS FOR THE 3.0 LITER RESERVOIR. SEPARATE REPORTS WILL BE ENTERED FOR THE 3-SPIKE DISPOSABLE SET AND DUAL PATIENT LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146206 THE BELMONT RAPID INFUSER THERMAL INFUSION FLUID WARMER LGZ BELMONT MEDICAL TECHNOLOGIES 3.0 LITER RESERVOIR 2020-01 03 00896128002008

    Patients

    Seq Age Sex Outcome Treatment
    1