BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2799018 · Received October 22, 2012

    Report

    Report Number
    1416980-2012-02952
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 28, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE 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. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE A CLEARLINK SECONDARY MEDICATION SET IN WHICH A NO FLOW OCCURRED WHEN IN USE WITH AN UNKNOWN CAREFUSION PRIMARY SET. ACCORDING TO THE REPORT, THE NURSE OBSERVED A NO FLOW AFTER CONNECTING THE SECONDARY SET TO THE UPPER Y-SITE ON THE PRIMARY SET. THE SECONDARY AND PRIMARY SETS WERE PRIMED WITHOUT ISSUE. THE ALLEGED DEFECT OCCURRED WHEN THE SECONDARY SET WAS CONNECTED TO THE LUER ACTIVATED DEVICE ON THE CAREFUSION SET. THE PRIMARY SET WAS IN USE WITH A CAREFUSION ALARIS INFUSION PUMP. THE TUBING WAS SWITCHED OUT AND THERAPY CONTINUED AS NORMAL. 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
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 CAREFUSION PRIMARY SET| CAREFUSION ALARIS INFUSION PUMP