BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2685351 · Received August 7, 2012

    Report

    Report Number
    6000001-2012-13051
    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 REPORTED CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    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

    A 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 IS ATTACHED TO AN UNKNOWN HOSPIRA PRIMARY SET AND A CLAVE LUER ACTIVATED DEVICE, THE CAREFUSION PUMP ALARMS DOWNSTREAM OCCLUSION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    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| HOSPIRA PLUMP PUMP| UNKNOWN HOSPIRA PRIMARY SET