BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2915761 · Received January 15, 2013

    Report

    Report Number
    1416980-2013-01022
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 24, 2012
    Report Date
    December 24, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE CONDITION WAS CONFIRMED. THIS IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE CAUSE WAS DETERMINED TO BE A FAULTY SAFETY SLIDE CLAMP ASSEMBLY. THE DEVICE WAS RETURNED UNREPAIRED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, A DUAL CHANNEL FLOGARD VOLUMETRIC INFUSION PUMP WAS FOUND TO HAVE A DEFECTIVE SLIDE CLAMP ASSEMBLY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22361 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1