BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2842937 · Received November 21, 2012

    Report

    Report Number
    1416980-2012-05782
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 28, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS REPAIRED ON-SITE AT THE CUSTOMER FACILITY BY A BAXTER FIELD SERVICE TECHNICIAN, AND THE CONDITION WAS CONFIRMED. THIS CONDITION IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF ANOTHER CONDITION. THE CAUSE WAS DETERMINED TO BE MISLOADING SENSORS. TO CORRECT THE CONDITION, THE FORCE SENSING RESISTORS WERE REPLACED.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, A FLOGARD INFUSION PUMP WAS FOUND TO HAVE EXPERIENCED AN OCCURRENCE OF FAILURE CODE 38. THIS WAS NOT REPORTED BY THE CUSTOMER. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1