BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAEMOFILTRATION SET

    MDR report key: 2133773 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07829
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    July 17, 2010
    Report Date
    July 20, 2010
    Manufacturer
    HAEMOTRONICS SPA
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL INSPECTION AND PERFORMANCE TESTS WERE PERFORMED. THERE WAS A PINHOLE FOUND AT THE EDGE OF THE BAG. THIS COMPLAINT WAS CONFIRMED IN THE LAB AND BY THE SUPPLIER FOR A LEAK. THE BATCH REVIEW PROVIDED BY (B)(4) FOUND NO ANOMALIES DURING THE MANUFACTURING OF THE LOT. RENAL QUALITY ENGINEERING WILL CONTINUE TO MONITOR THIS PRODUCT FOR ADVERSE TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE. 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. THIS MDR IS BEING SUBMITTED AS PART OF BAXTER RENAL'S RETROSPECTIVE REVIEW & REMEDIATION PROJECT. THIS REPORT IS BEING FILED LATE TO FULFILL BAXTER'S COMMITMENT TO PERFORM A TWO YEAR RETROSPECTIVE REVIEW OF RENAL COMPLAINTS IN RESPONSE TO FDA-WARNING LETTER CHI-07-10.

    Description of Event or Problem · 1

    IT WAS NOTED THE TUBING WAS LEAKING DURING USE. HOWEVER, THE REPORTER COULD NOT DISCOVER WHERE THE LEAK POINT WAS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1