BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUASET

    MDR report key: 2133774 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07830
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    October 24, 2009
    Report Date
    November 12, 2009
    Manufacturer
    HAEMOTRONICS SPA
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 SAMPLE WAS NOT AVAILABLE OR RECEIVED. HAEMOTRONIC RECEIVED PHOTOS OF THE DEVICE SHOWING BLOOD INSIDE THE HEPARIN SYRINGE. ON THE BASIS OF THE PHOTOS RECEIVED, IT IS CLEAR THAT SOMETHING HAPPENED TO THE CHECK VALVE BECAUSE IT WAS CLEAR THAT BLOOD WAS PRESENT INSIDE THE HEPARIN SYRINGE, BUT IT WAS IMPOSSIBLE TO UNDERSTAND THE REASON OF THE VALVE MALFUNCTION SOLELY THROUGH ANALYSIS OF THE PHOTOS. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. NO CORRECTIVE/PREVENTIVE ACTION HAS BEEN TAKEN BECAUSE THE SPECIFIC DEFECT AND RELEVANT ROOT CAUSES WERE NOT ABLE TO BE IDENTIFIED.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER (B)(4) A DEFECTIVE BLOOD BACKFLOW VALVE OF A HEMOFILTRATION KIT AQUASET (CODE AQUASET 12 LOT N0918) AND BLOOD WAS OBSERVED INTO THE HEPARIN SYRINGE IN SPITE OF A PROGRAMMED FLOW RATE. THE SAMPLE WAS NOT AVAILABLE. THE EVENT OCCURRED DURING PATIENT USE, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUASET SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALV FJK HAEMOTRONICS SPA N0918

    Patients

    Seq Age Sex Outcome Treatment
    1 HEMODIALYSIS HARDWARE