BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILTRATION INFUSION LINE BM25

    MDR report key: 1984340 · Received February 10, 2011

    Report

    Report Number
    1423500-2011-01759
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    August 9, 2010
    Report Date
    August 16, 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). 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 ACTUAL SAMPLE WAS RECEIVED AND EVALUATED BY BAXTER AND (B)(4). THE COMPLAINT WAS CONFIRMED THAT THERE WAS A LEAK IN THE WARMING BAG. THE SUPPLIER'S INVESTIGATION REPORT INDICATES THAT THE HOLE WAS DUE TO A BREAK IN THE FLAT TUBING. THE ROOT CAUSE COULD NOT BE DETERMINED DUE TO THE LOW NUMBER OF DEFECTIVE PIECES. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) THAT DURING TREATMENT, THERE WAS A LEAK FOUND IN THE WARMING BAG. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILTRATION INFUSION LINE BM25 SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK HAEMOTRONICS SPA B1076

    Patients

    Seq Age Sex Outcome Treatment
    1