BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3033517 · Received April 3, 2013

    Report

    Report Number
    1416980-2013-08277
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BAXTER HEALTHCARE - BUFFALO GROVE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED CONDITION OF "BATTERY CANNOT CHARGE" WAS CONFIRMED BY TECHNICAL SERVICES AS A FUSE ISSUE. THE FUSES WERE FOUND TO BE DAMAGED. THE FUSES WERE REPLACED TO RESOLVE THE PROBLEM. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER THAT A FLOGARD PUMP HAD A BATTERY THAT WAS NOT ABLE TO CHARGE. PROCESS STEP IS UNKNOWN. NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION WAS REPORTED WHEN THIS EVENT WAS RECEIVED. ADDITIONAL INFORMATION IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136601 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - BUFFALO GROVE

    Patients

    Seq Age Sex Outcome Treatment
    1