BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINE SET FOR AQUARIUS

    MDR report key: 1903714 · Received November 20, 2010

    Report

    Report Number
    1423500-2010-06022
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BAXTER ( 765 )SWITZERLAND SA
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RECEIVED 1 AQUALINE, LINE SET FOR AQUARIUS USED. THIS WAS DISINFECTED WITH BLEACH SOLUTION AND SOME BLOOD RESIDUE WAS STILL IN THE LINE AND COULD NOT BE CLEANED OUT. THIS BLOODLINE WAS CONSIDERED BIOHAZARDOUS AND NO OTHER TESTING COULD BE PERFORMED. THIS COMPLAINT COULD NOT BE CONFIRMED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ROOT CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION AVAILABLE. THE RETURNED SAMPLE COULD NOT BE EVALUATED DUE TO RESIDUAL BLOOD RESIDUE AFTER DISINFECTION. THEREFORE, NO ROOT CAUSE CAN BE DETERMINED THROUGH SAMPLE INSPECTION. HAEMOTRONIC REVIEWED THE DEVICE HISTORY FILE AND "DIDN'T FIND ANYTHING OF ANOMALOUS" SINCE THERE IS NOT ENOUGH INFORMATION TO DETERMINE ANY POSSIBLE PRODUCT FAILURE SOURCE, NO POTENTIAL CAUSES CAN BE LISTED. RENAL QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR THESE PRODUCT LINES FOR ADVERSE TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT ORIGINATED AS A RESULT OF A NURSE NOTING THERE WERE A LOT OF BUBBLES IN THE FILTRATE LINE. THEN CHECKED THE TUBING AND FOUND THE FILTRATE LINE WHICH CONNECTED THE FILTRATE PUMP WAS DAMAGED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT.

    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 BAXTER ( 765 )SWITZERLAND SA B101688

    Patients

    Seq Age Sex Outcome Treatment
    1