BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLUMAT MC AGILIA BR

    MDR report key: 17961927 · Received October 18, 2023

    Report

    Report Number
    3000240707-2023-00319
    Event Type
    Malfunction
    Date Received
    October 18, 2023
    Date of Event
    September 2, 2023
    Report Date
    October 18, 2023
    Manufacturer
    FRESENIUS VIAL S.A.S.
    Product Code
    FRN
    PMA / PMN Number
    K121613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: "THERE WAS AN EXPLOSION DURING USE, THE EQUIPMENT WAS PLUGGED IN AND INFUSED WITH POTASSIUM PHOSPHATE. NO DAMAGE TO THE PATIENT WAS REPORTED. ADDITIONAL INFO RECEIVED: AN EVALUATION WAS CARRIED OUT BY THE LOCAL DEPARTMENT, WHO IS QUALIFIED BY THE PU. A TECHNICAL ASSESSMENT OF THE EQUIPMENT WAS CARRIED OUT AND OUR ANALYSIS REVEALED THAT THE FIRE APPARENTLY STARTED ON THE OUTSIDE OF THE EQUIPMENT, PRECISELY WHERE THE POWER CABLE IS INSERTED. AS THE INCIDENT ORIGINATED FROM AN EXTERNAL CAUSE, NOT DIRECTLY FROM THE EQUIPMENT, IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE INCIDENT, AS IT WAS AN EXTERNAL CAUSE. WE ANALYZED THE INTERIOR AND IT SHOWED NO SIGNS OF BURNING IN ITS COMPONENTS. WE REPLACED THE CHARGING COMPARTMENT OF THE EQUIPMENT THAT HAD BEEN DAMAGED, AND IT WORKED PERFECTLY WITH ALL ITS SPECIFICATIONS." REPORTING DUE TO THE REFERENCED ISSUE AS A CONSERVATIVE MEASURE. NO ADVERSE EVENT REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1750150 VOLUMAT MC AGILIA BR INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown