BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER

    MDR report key: 7954319 · Received October 10, 2018

    Report

    Report Number
    1219702-2018-00037
    Event Type
    Malfunction
    Date Received
    October 10, 2018
    Date of Event
    September 9, 2018
    Report Date
    October 10, 2018
    Manufacturer
    BELMONT INSTRUMENT LLC
    Product Code
    LGZ
    UDI-DI
    10896128002760
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING THE COMPLAINT RECEIVED ON (B)(6) 2018, BELMONT'S CLINICAL SPECIALIST REQUESTED THE SERIAL NUMBER TO THE UNIT. THE INITIAL REPORT FROM THE USER FACILITY STATED THAT THE UNIT WAS IN BIOMED AND RISK MANAGEMENT NEEDED TO PERFORM AN INVESTIGATION. WHEN A SECOND VERY SIMILAR REPORT INVOLVING RAPID INFUSER S/N (B)(4) WAS RECEIVED FROM THE BIOMED ON (B)(6) 2018, ATTEMPTS WERE MADE TO DETERMINE WHETHER BOTH REPORTS WERE IN REFERENCE TO THE SAME EVENT. AS OF THE DATE OF THIS REPORT, NO RESPONSE FROM THE USER FACILITY HAS BEEN RECEIVED. THE BELMONT RAPID INFUSER, S/N (B)(4), WAS RETURNED FOR INVESTIGATION AND WAS TESTED USING OUR STANDARD OPERATING PROCEDURES. UPON RECEIPT, THERE WAS A BURN MARK NEAR THE POWER ENTRY MODULE AS REPORTED BY THE CUSTOMER; OTHERWISE, THE UNIT PERFORMED ACCORDING TO OUR SPECIFICATIONS UPON RECEIPT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE BELMONT CLINICAL SPECIALIST RECEIVED AN EMAIL FROM THE TRAUMA PROGRAM MANAGER AT THE USER FACILITY, WHO REPORTED THAT THE BELMONT RAPID INFUSER SPARKED NEAR THE POWER CORD ON THE BACK OF THE MACHINE AND SHOCKED THE RN WHO WAS ATTEMPTING TO PRIME THE LINE. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE THE RN NOR TO THE PATIENT. THE SERIAL NUMBER OF THE IMPLICATED UNIT WAS NOT REPORTED FOLLOWING THIS INCIDENT. ON (B)(6) 2018, WE RECEIVED A SECOND REPORT FROM THE SAME USER FACILITY, INVOLVING BELMONT RAPID INFUSER S/N (B)(4), STATING THAT THE UNIT LOST POWER FOLLOWING A SPARK NEAR THE POWER CORD WHICH SUBSEQUENTLY LEFT A BURN MARK NEAR THE LOCATION. THIS REPORT, HOWEVER, STATED THAT NO PATIENT WAS INVOLVED AND DID NOT MAKE MENTION OF THE RN BEING SHOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794683 THE BELMONT RAPID INFUSER THERMAL INFUSION FLUID WARMER LGZ BELMONT INSTRUMENT LLC RI-2 10896128002760

    Patients

    Seq Age Sex Outcome Treatment
    1