BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINE SET FOR AQUARIUS

    MDR report key: 1964301 · Received January 19, 2011

    Report

    Report Number
    1423500-2011-00784
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    November 1, 2010
    Report Date
    December 27, 2010
    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). EVALUATION OF THE SAMPLE BY BAXTER AND HAEMOTRONIC CONFIRMED THAT THERE WAS A LEAKAGE IN THE YELLOW TUBING. A BATCH REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS UNKNOWN. DUE TO INSUFFICIENT INFORMATION AVAILABLE, ROOT CAUSE COULD NOT BE DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    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 NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THIS INCIDENT WAS PRIOR TO PATIENT USE AND NO PATIENT WAS CONNECTED.

    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