BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2821887 · Received November 7, 2012

    Report

    Report Number
    1416980-2012-04238
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 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). EVALUATION SUMMARY: THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE CONDITION WAS CONFIRMED BY SERVICE. THIS CONDITION IS AN ANCILLARY SERVICE EVENT OPENED DURING THE INVESTIGATION OF ANOTHER CONDITION. THE CAUSE WAS IDENTIFIED TO BE A MISSING P2 PUMP HEAD DOOR. THE DEVICE WILL BE RETURNED UNREPAIRED BECAUSE AN APPROVAL FOR THE REPAIR WAS NOT RECEIVED.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, A FLOGARD INFUSION PUMP WAS FOUND TO BE MISSING A P2 PUMP HEAD DOOR. 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