BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2143324 · Received June 29, 2011

    Report

    Report Number
    6000001-2011-09157
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY AWAITING EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER?S REPORTED CONDITION OF A FLO-GARD INFUSION PUMP WITH A BROKEN DOOR WAS CONFIRMED AND REPRODUCED DURING EVALUATION AS THE LATCH AREA HAD DAMAGED. THE CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE DEFECTS IN THE DOOR LATCH/HINGE AREA. THE PUMP HEAD DOOR, OCCLUSION DETECTORS, BUMPERS, AND PUMP HEAD COVER WERE REPLACED TO FIX THE REPORTED CONDITION. THE OCCLUSION SENSORS CALIBRATION WAS ALSO PERFORMED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FLO-GARD INFUSION PUMP WITH A MALFUNCTION OF DOOR BROKEN WITHIN THE GENERAL PATIENT WARD. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. ACCORDING TO THE HOSPITAL REPRESENTATIVE, THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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