BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3951044 · Received July 22, 2014

    Report

    Report Number
    1416980-2014-23654
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    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 FLOGARD INFUSION PUMP WAS SERVICED ON-SITE. A VISUAL INSPECTION, POWER ON SELF-TEST, AND AN INTERNAL BATTERY TEST WERE PERFORMED. DURING THE VISUAL INSPECTION IT WAS IDENTIFIED THAT THE POWER CORD WAS DAMAGED. THE CAUSE OF THE DAMAGE IS UNKNOWN. THE POWER CORD WAS REPLACED, THE PUMP PASSED ALL TESTING AND THE PUMP WAS RETURNED TO THE CUSTOMER IN GOOD WORKING ORDER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING ON-SITE SERVICE, THE BAXTER SERVICE TECHNICIAN FOUND THAT THE FLOGARD INFUSION PUMP HAD A DAMAGED POWER CORD. THIS MALFUNCTION WAS IDENTIFIED DURING SERVICE; THEREFORE THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428327 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1