BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINE SET FOR AQUARIUS

    MDR report key: 1964300 · Received January 19, 2011

    Report

    Report Number
    1423500-2011-00783
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 27, 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). EVALUATION OF THE SAMPLE BY BAXTER FOUND THAT THERE WAS A LEAKAGE IN THE GREEN TUBING, DETECTED DURING THE DISINFECTION PROCESS. BECAUSE THE SAMPLE COULD NOT BE COMPLETELY DISINFECTED, IT WAS DEEMED BIOHAZARDOUS AND NOT SENT TO HAEMOTRONIC FOR FURTHER EVALUATION. DUE TO INSUFFICIENT INFORMATION, ROOT CAUSE COULD NOT BE DETERMINED. ACCORDING TO HAEMOTRONIC'S INVESTIGATION REPORT, A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. 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). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

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

    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 HAEMOTRONICS SPA B104301

    Patients

    Seq Age Sex Outcome Treatment
    1 HEMODIALYSIS MACHINE