BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3840829 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17412
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    SHARP CORPORATION OSAKA JAPAN
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION INFORMATION: THE PUMP WAS SERVICED ON-SITE. A VISUAL INSPECTION, ALARM LOG REVIEW, BATTERY TESTING AND POWER ON SELF-TEST WERE PERFORMED. DURING THE VISUAL INSPECTION IT WAS IDENTIFIED THAT THE ROLLER LATCH WAS BROKEN. THE ROLLER LATCH WAS REPLACED TO FIX THE FOUND CONDITION. THE PUMP PASSED ALL TESTING AND WAS RETURNED TO THE CUSTOMER IN 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
    318224 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1