BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2930012 · Received January 25, 2013

    Report

    Report Number
    1416980-2013-01978
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    BRZ
    PMA / PMN Number
    K993120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION CONFIRMED A SEPARATION BETWEEN THE TUBING AND SPIKE; THE ROOT CAUSE WAS NOT DETERMINED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF THE EVALUATION OR IF ANY RELEVANT ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE OF A CLEARLINK Y-TYPE BLOOD SET IN WHICH THE TUBING SEPARATED FROM THE DRIP CHAMBER. ACCORDING TO THE REPORT, THE ALLEGED DEFECT OCCURRED WHEN THERAPY WAS INITIATED ON A PATIENT IN THE OPERATING ROOM. THE MEDICATION BEING ADMINISTERED WAS AN UNKNOWN BLOOD SOLUTION. THE REPORTER INDICATED THAT THE SEPARATION RESULTED IN BLOOD SPRAYING ON THE NURSE. THE CLEARLINK Y-TYPE BLOOD SET WAS CHANGED OUT AND THERAPY CONTINUED AS NORMAL. THEREFORE, THERE WERE NO REPORTS OF PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35840 ACCESS SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BLOOD SOLUTION