BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3132785 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13477
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS EVALUATED AT THE CUSTOMER SITE. THE ALARM HISTORY REVIEW AND VISUAL INSPECTION CONFIRMED THAT THE DEVICE HAD EXPERIENCED THE REPORTED ALARM. IT WAS DETERMINED THAT THE ROOT CAUSE OF THE ALARM WAS A DEFECTIVE DOOR MAGNET. TO CORRECT THE ISSUE, THE DOOR MAGNET WAS REPLACED AND THE DEVICE WAS RETURNED TO GOOD WORKING CONDITION. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP WAS EXPERIENCING A "DOOR OPEN/CLOSE CLAMP" ALARM. THIS OCCURRED WHEN THE PUMP WAS POWERED ON. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235162 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1