BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2913958 · Received January 14, 2013

    Report

    Report Number
    1416980-2013-00973
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP WAS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE HAS NOT HAD PREVIOUS SERVICE. A DEVICE HISTORY REVIEW WAS PERFORMED; NO NON-CONFORMITIES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE REPORTED CONDITION OF A DAMAGED POWER CORD WAS NOT CONFIRMED AS THE SAMPLE WAS NOT AVAILABLE AND NO EVALUATION COULD BE PERFORM.

    Description of Event or Problem · 1

    A CUSTOMER CALLED BAXTER CORPORATE PRODUCT SURVEILLANCE TO REPORT A FLOGARD INFUSION PUMP IN WHICH THE POWER CORD IS DAMAGED. ACCORDING TO THE REPORT, THE PLASTIC COATING IS TORN AND THE PUMP WAS TAKEN OUT OF SERVICE AT THE FACILITY. THE EVENT OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT, INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19965 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1