BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINE SET FOR AQUARIUS

    MDR report key: 2000886 · Received February 24, 2011

    Report

    Report Number
    1423500-2011-02429
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 15, 2011
    Manufacturer
    HAEMOTRONICS SPA
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS RECEIVED AND EVALUATED. EVALUATION OF THE SAMPLE BY BAXTER AND HAEMOTRONIC SHOWED A SLICE IN THE YELLOW TUBING, CONFIRMED BY LEAK TEST AT BAXTER. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED DUE TO THE INSUFFICIENT INFORMATION AVAILABLE. ACCORDING TO HAEMOTRONIC'S INVESTIGATION REPORT, THE DEVICE HISTORY FILE REVIEW CONDUCTED AND NO ISSUES WERE FOUND. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. IF THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER (B)(4) THAT DURING PREFILLING A LEAK WAS NOTICED IN THE TUBING. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINE SET FOR AQUARIUS SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK HAEMOTRONICS SPA

    Patients

    Seq Age Sex Outcome Treatment
    1