BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUALINE S

    MDR report key: 2143326 · Received June 29, 2011

    Report

    Report Number
    1423500-2011-08467
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    April 14, 2010
    Report Date
    April 14, 2010
    Manufacturer
    HAEMOTRONICS SPA
    Product Code
    FJK
    PMA / PMN Number
    K063293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).A SAMPLE WAS NOT AVAILABLE FOR THIS COMPLAINT BECAUSE IT WAS CONTAMINATED WITH BLOOD. WITHOUT ANY DEFECTIVE SAMPLE AND POOR INFORMATION IT IS IMPOSSIBLE FOR US TO UNDERSTAND WHAT HAPPENED AND POSSIBLE CAUSES. THE DEVICE HISTORY FILE CANNOT BE REVIEWED LOT BECAUSE THE LOT WAS UNKNOWN. NO CORRECTIVE/PREVENTIVE ACTION HAS BEEN TAKEN BECAUSE WE WERE NOT ABLE TO UNDERSTAND WHAT HAPPENED AND RELEVANT ROOT CAUSES.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED BY BAXTER (B)(4) FROM (B)(6) HOSPITAL VIA THE ACCOUNT MANAGER. IT WAS REPORTED THAT THERE WAS A BLOOD LEAK (SPLIT) FROM THE AQUALINE TUBING SET INSIDE THE BLOOD PUMP OF AN AQUARIUS MACHINE. THE UNIT DECIDED TO REMOVE THE PATIENT FROM TREATMENT. THERE WAS NO PATIENT/USER/OTHER PERSON'S INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUALINE S SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK HAEMOTRONICS SPA 1500001906

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR HEMODIALYSIS MACHINE