BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2802833 · Received October 24, 2012

    Report

    Report Number
    1416980-2012-03056
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE CONDITION WAS CONFIRMED. THIS IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF ANOTHER CONDITION. THE CAUSE WAS DETERMINED TO BE DAMAGE TO THE PUMP HEAD DOOR ASSEMBLY. TO CORRECT THE CONDITION, THE PUMP HEAD DOOR ASSEMBLY WAS REPLACED.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, A FLO-GARD INFUSION PUMP WAS FOUND TO HAVE A DAMAGED PUMP HEAD DOOR ASSEMBLY NEAR THE LATCH AREA. 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