BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2685377 · Received August 7, 2012

    Report

    Report Number
    6000001-2012-13052
    Event Type
    Malfunction
    Date Received
    August 7, 2012
    Date of Event
    July 1, 2012
    Report Date
    July 14, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K811078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. HOWEVER, A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BAXTER SALES REPRESENTATIVE EMAILED BAXTER CORPORATE PRODUCT SURVEILLANCE REGARDING A FACILITY REPORT OF A PEDIATRIC EXTENSION SET IN WHICH A NO FLOW WAS OBSERVED. ACCORDING TO THE REPORT, WHEN THE EXTENSION SET IT ATTACHED TO AN UNKNOWN HOSPIRA PRIMARY SET AND A CLAVE LUER ACTIVATED DEVICE, THE CAREFUSION PUMP IS ALARMING DOWNSTREAM OCCLUSION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR11I16079

    Patients

    Seq Age Sex Outcome Treatment
    1 CLAVE LUER ACTIVATED DEVICE| CAREFUSION PUMP| UNKNOWN HOSPIRA PRIMARY SET, CLAVE LUER ACTIVATED