BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 5112279 · Received September 29, 2015

    Report

    Report Number
    1416980-2015-37516
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Date of Event
    September 8, 2015
    Report Date
    September 29, 2015
    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

    COMPLAINT NO: (B)(4). THE DEVICE WAS SERVICED BY A SERVICE TECHNICIAN. THIS IS AN ANCILLARY SERVICE EVENT. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE EVENT. VISUAL INSPECTION, FUNCTIONAL TESTING AND AN ALARM LOG REVIEW WERE PERFORMED. THE DAMAGED LATCH ROLLER WAS IDENTIFIED DURING VISUAL INSPECTION. THE CAUSE OF THE CONDITION WAS NOT DETERMINED. TO CORRECT THE CONDITION, THE LATCH ROLLER WAS REPLACED. THE DEVICE WAS SERVICED TO MEET FUNCTIONAL SPECIFICATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING PRODUCT SERVICE BY A SERVICE TECHNICIAN, A FLO-GARD INFUSION PUMP HAD A DAMAGED LATCH ROLLER. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641984 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1