BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 6144415 · Received December 5, 2016

    Report

    Report Number
    1416980-2016-18020
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Date of Event
    November 10, 2016
    Report Date
    December 29, 2016
    Manufacturer
    BAXTER HEALTHCARE- SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. AN ALARM LOG REVIEW, FUNCTIONAL TESTING, AND VISUAL INSPECTION WERE PERFORMED. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE EVENT. AN F-35 ALARM WAS NOT FOUND DURING EVALUATION; HOWEVER, AN F-38 (MALFUNCTION IN TUBE MISLOADING DETECTION CIRCUITRY) ALARM WAS IDENTIFIED DURING THE ALARM LOG REVIEW AND FUNCTIONAL TESTING. THE CAUSE OF THE F-38 ALARM WAS DETERMINED TO BE DAMAGED AND OUT OF SPECIFICATION FORCE SENSING RESISTORS. THE DEVICE WAS REMOVED FROM SERVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 F35 ALARM (FRONT PANEL KEY WAS PRESSED FOR MORE THAN 40 SECONDS). THIS OCCURRED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795588 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE- SINGAPORE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1