BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER

    MDR report key: 7874079 · Received September 13, 2018

    Report

    Report Number
    1219702-2018-00030
    Event Type
    Malfunction
    Date Received
    September 13, 2018
    Date of Event
    August 15, 2018
    Report Date
    September 13, 2018
    Manufacturer
    BELMONT INSTRUMENT LLC
    Product Code
    LGZ
    UDI-DI
    10896128002760
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RETURNED AND WAS TESTED USING OUR STANDARD OPERATING PROCEDURES. WE WERE UNABLE TO CONFIRM THE CUSTOMER COMPLAINT OF AN "OVER TEMPERATURE" ALARM; THE UNIT PERFORMED ACCORDING TO OUR SPECIFICATIONS UPON RECEIPT. WE WERE UNABLE TO INVESTIGATE THE DISPOSABLE SET AS IT WAS DISCARDED AT THE HOSPITAL. UPON REVIEWING PAST SHIPPING RECORDS, WE WERE UNABLE TO CONCLUSIVELY DETERMINE THE LOT NUMBER OF THE DISPOSABLE SET AND THEREFORE UNABLE TO FURTHER INVESTIGATE. THE USER FACILITY HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION ABOUT THE EVENT AND STATUS OF THE PATIENT, BUT HAS NOT YET RESPONDED TO OUR REQUESTS. WITHOUT FURTHER INFORMATION, IT IS DIFFICULT TO DETERMINE WHAT OCCURRED IN THIS INCIDENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE UNIT EXHIBITED AN "OVER TEMPERATURE" ALARM DURING A CASE INVOLVING A PATIENT. THE DISPOSABLE SET WAS DISCARDED DUE TO BLOOD CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713029 THE BELMONT RAPID INFUSER THERMAL INFUSION FLUID WARMER LGZ BELMONT INSTRUMENT LLC RI-2 10896128002760

    Patients

    Seq Age Sex Outcome Treatment
    1