BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 5873114 · Received August 12, 2016

    Report

    Report Number
    1416980-2016-14054
    Event Type
    Malfunction
    Date Received
    August 12, 2016
    Date of Event
    July 18, 2016
    Report Date
    September 26, 2016
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. VISUAL INSPECTION, FUNCTIONAL TESTING AND A REVIEW OF THE ALARM LOG WERE PERFORMED. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE F23 ALARM (P50 (IRQ INTERRUPT PORT) REMAINS HIGH) WAS IDENTIFIED DURING FUNCTIONAL TESTING AND THE REVIEW OF THE ALARM LOG. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE DUE TO THE CPU BOARD WAS FOUND DAMAGED. THE FLO-GARD INFUSION PUMP WAS TAKEN OUT OF SERVICE. 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 PRESENTED AN F-23 (P50 (IRQ INTERRUPT PORT) REMAINS HIGH) ALARM. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523472 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1