BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2964150 · Received February 15, 2013

    Report

    Report Number
    1416980-2013-03972
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K120443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE CAN NOT BE DETERMINED. A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    A SALES REPRESENTATIVE CALLED BAXTER CORPORATE PRODUCT SURVEILLANCE TO REPORT A ONELINK CATHETER EXTENSION SET WHICH WAS ALLEGED TO CAUSE HEMOLYSIS. ACCORDING TO THE REPORT, THE FACILITY USED THE EXTENSION SET TO DRAW AN UNKNOWN AMOUNT OF BLOOD INTO AN EMPTY VACUTAINER. THE LAB AT THE FACILITY NOTIFIED THE EMERGENCY ROOM NURSE THAT THE BLOOD IN THE VACUTAINER UNDERWENT HEMOLYSIS. THE FACILITY THEN USED A CAREFUSION MAXPLUS CLEAR EXTENSION SET AND RECEIVED NORMAL BLOOD RESULTS BACK. THE FACILITY IS CURRENTLY UNDERGOING THE ONELINK EVALUATION TESTING. THE EVENT OCCURRED AFTER PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT, INJURY, MEDIAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68139 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1