BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3840425 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17356
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    SHARP CORPORATION OSAKA JAPAN
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). EVALUATION INFORMATION: THE FLOGARD INFUSION PUMP WAS SERVICED ON SITE. VISUAL INSPECTION, FORCE SENSING RESISTOR TESTING AND AN ALARM LOG REVIEW WERE PERFORMED. DURING VISUAL INSPECTION IT WAS IDENTIFIED THAT THE DOOR LATCH ROLLER WAS DAMAGED, CAUSE UNKNOWN. THE LATCH ROLLER WAS REPLACED TO CORRECT THIS CONDITION. THE PUMP PASSED ALL TESTING AND WAS RETURNED TO GOOD WORKING ORDER. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR 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 LATCH ROLLER. 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
    318468 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1