BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINE SET FOR AQUARIUS

    MDR report key: 1932637 · Received December 19, 2010

    Report

    Report Number
    1423500-2010-07044
    Event Type
    Malfunction
    Date Received
    December 19, 2010
    Date of Event
    November 25, 2010
    Report Date
    November 25, 2010
    Manufacturer
    HAEMOTRONICS SPA
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    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 WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    THIS IS A CASE, WHICH WAS REPORTED TO BAXTER. THE COMPLAINT WAS RECEIVED AND REFERS TO AN INCIDENT INVOLVING A LINE SET FOR AQUARIUS. THE REPORTER STATES THAT A PERSISTENT ALARM " NO FLUID CHAMBER DETECTED" DURING THE RECIRCULATION MODE ON A AQUARIUS MACHINE. ON INSPECTION THE DEGASSING CHAMBER WAS FOUND TO BE MISSHAPED/ OVAL SHAPED AND UNABLE TO FIT CORRECTLY IN THE DEGASSING CHAMBER HOLDER. THE SET WAS THEN DISPOSED OF BY THE UNIT. NO PATIENT INJURY HAS BEEN REPORTED AS THIS WAS DISCOVERED PRIOR TO PATIENT USE.

    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 N10229

    Patients

    Seq Age Sex Outcome Treatment
    1