BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 6326883 · Received February 13, 2017

    Report

    Report Number
    1416980-2017-01226
    Event Type
    Malfunction
    Date Received
    February 13, 2017
    Date of Event
    January 19, 2017
    Report Date
    March 15, 2017
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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, POWER ON SELF TEST 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 WAS IDENTIFIED DURING POWER ON SELF TEST AND REVIEW OF THE ALARM LOG. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE DAMAGED CPU BOARD. THE DEVICE WAS REMOVED FROM SERVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLO-GARD INFUSION PUMP HAD AN F-23 (P50 (IRQ INTERRUPT PORT) REMAINS HIGH) ALARM. IT WAS NOT SPECIFIED WHEN IN THE PROCESS THIS OCCURRED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108714 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1