BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2974299 · Received February 22, 2013

    Report

    Report Number
    1416980-2013-04468
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 31, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    BRZ
    PMA / PMN Number
    K993120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED AND FOUND A HOLE IN THE OUTLET PORT. THE SAMPLE WAS RE-PRIMED, FOR FUNCTIONAL TESTING, AND A LEAK WAS FOUND. THE CUSTOMER REPORTED CONDITION WAS CONFIRMED, HOWEVER THE CAUSE COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK FENWAL BLOOD SET HAD A LEAK. THE FACILITY REPORTED THAT THE LEAK OCCURRED AT THE CONNECTION OF THE TUBING AND THE DRIP CHAMBER DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77715 ACCESS SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE R12J22018

    Patients

    Seq Age Sex Outcome Treatment
    1