BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 4210356 · Received October 29, 2014

    Report

    Report Number
    1416980-2014-37880
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. THIS IS AN ANCILLARY SERVICE EVENT. VISUAL INSPECTION, POWER ON SELF-TEST AND ALARM LOG REVIEW WAS PERFORMED. DURING ALARM LOG REVIEW THE F-2 ALARM WAS FOUND; THE CAUSE OF THIS WAS A DAMAGED LATCH ROLLER. TO CORRECT THE CONDITION, THE LATCH ROLLER WAS REPLACED. 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

    DURING PRODUCT SERVICE BY A FIELD SERVICE TECHNICIAN, A FLO-GARD INFUSION PUMP WAS FOUND TO HAVE EXPERIENCED AN F-2 ALARM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691556 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1