BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3234068 · Received July 18, 2013

    Report

    Report Number
    1416980-2013-18868
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. EVALUATION SUMMARY: THE SAMPLE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE REPORTED CONDITION OF A MALFUNCTION WAS CONFIRMED AS THE F-94 ALARM, AS IT WAS THE ONLY ALARM TO OCCUR DURING SERVICE. THE CAUSE OF THE F-94 ALARM WAS DETERMINED TO BE DEFECTIVE MAIN BATTERIES ASSOCIATED WITH A NON-FUNCTIONAL POWER CORD. AN INOPERATIVE POWER CORD WOULD PREVENT THE MAIN BATTERIES FROM CHARGING AND CAUSE THE MAIN BATTERIES TO GO INTO DEEP DISCHARGE. THE MAIN BATTERIES AND POWER CORD WERE REPLACED TO RESOLVE THE ISSUE. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP HAD AN UNSPECIFIED MALFUNCTION. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333587 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1