BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUALINE

    MDR report key: 2213443 · Received August 16, 2011

    Report

    Report Number
    1423500-2011-10772
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 1, 2011
    Manufacturer
    HAEMOTRONICS SPA
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. SAMPLE WAS NOT RETURNED; THEREFORE, NO EVALUATION COULD BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER (B)(4) THAT A BLOOD LEAK OCCURRED FROM THE BLOOD PUMP HOUSING AFTER 7 HOURS OF TREATMENT. AFTER FURTHER INSPECTION THE LEAK WAS DUE TO A SPLIT IN THE BLOOD PUMP TUBING. THE TREATMENT WAS IMMEDIATELY TERMINATED AND MACHINE SENT TO BIO MED. THERE WAS PATIENT INVOLVEMENT HOWEVER NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUALINE SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK HAEMOTRONICS SPA B102272

    Patients

    Seq Age Sex Outcome Treatment
    1