BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL LINE W PRE FILTERCHAMBER FOR BM25

    MDR report key: 1908424 · Received November 26, 2010

    Report

    Report Number
    1423500-2010-06323
    Event Type
    Malfunction
    Date Received
    November 26, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 5, 2010
    Manufacturer
    HAEMOTRONICS SPA
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS RECEIVED AND EVALUATED. EVALUATION OF THE UNUSED SAMPLE BY BAXTER FOUND THAT THE CONNECTOR TO THE FILTER HAD BROKEN OFF. THE SAMPLE WAS SENT TO HAEMOTRONIC FOR FURTHER EVALUATION, AND IT WAS CONFIRMED THAT THE CONNECTOR HAD SNAPPED FROM THE TRANSDUCER PROTECTOR. THE COMPLAINT DESCRIBES A LEAK IN THE ARTERIAL TUBING AND THEREFORE THE SAMPLE THAT WAS SENT BY THE CUSTOMER DOES NOT CONFIRM THE COMPLAINT. HAEMOTRONIC VISUALLY INSPECTED THE SAMPLE AND DETERMINED THAT THE BREAKAGE WAS NOT DUE TO SOLVENT APPLICATION OR WELDING DURING MANUFACTURE OF THE PRODUCT. ACCORDING TO THE INVESTIGATION REPORT, HAEMOTRONIC PERFORMED A BATCH REVIEW AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. DUE TO INSUFFICIENT INFORMATION, AND BEING UNABLE TO CONFIRM THE COMPLAINT, NO ROOT CAUSE COULD BE DETERMINED. RENAL QUALITY ENGINEERING, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE DEVICE HAS BEGUN; HOWEVER, HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE EVALUATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED. 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.

    Description of Event or Problem · 1

    THIS REPORTS IS A RESULT OF A CUSTOMER CONTACTING BAXTER. THE CUSTOMER REPORTED THE ARTERIAL BLOOD LINE WITH PRE FILTER CHANGER FOR (B)(4). IT HAD LEAKED AT THE ARTERIAL TUBING DURING USE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL LINE W PRE FILTERCHAMBER FOR BM25 SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK HAEMOTRONICS SPA B10807

    Patients

    Seq Age Sex Outcome Treatment
    1