BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS AQUARIUS SYSTEM

    MDR report key: 1831579 · Received September 11, 2010

    Report

    Report Number
    2015691-2010-14044
    Event Type
    Malfunction
    Date Received
    September 11, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 12, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KDI
    PMA / PMN Number
    K070320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING DATE: 2009 METHOD, RESULT AND CONCLUSION WILL BE PROVIDED IN A FOLLOW UP SUBMISSION THE DEVICE IS SERVICED BY IN-HOSPITAL RENAL SERVICE TECHNICIANS AND EVALUATIONS ARE PERFORMED IN-SITU. THE RENAL TECHNICIANS COMMUNICATED THAT THEY WERE ONLY INFORMED REGARDING THE AIR DETECTOR ALARM (BY THE NURSING STAFF ON THE UNIT); THEY CHECKED FOR THIS ISSUE AND REPLACED THE HYDROPHOBIC FILTER. THE RENAL TECHNICIANS DID NOT HAVE ANY REPORT FROM THE UNIT REGARDING THE HEPARIN DRIVER ISSUE. A REQUEST HAS BEEN MADE FOR THE RENAL TECHNICIANS TO RE-EVALUATE THE DEVICE FOR THE SPECIFIED ISSUE WITH THE HEPARIN SYRINGE DRIVER. ADDITIONALLY, THE UNIT HAS BEEN INSTRUCTED TO REMOVE THE DEVICE FROM SERVICE UNTIL THE HEPARIN DRIVER HAS BEEN EVALUATED. THE EVALUATION RESULTS WILL BE COMMUNICATED IN A FOLLOW UP SUBMISSION. THE DHR REVIEW HAS SHOWN NO INDICATORS WHICH COULD BE RELATED TO THE COMPLAINT. THE DEVICE FULFILLED ALL RELEASE REQUIREMENTS DURING FINAL INSPECTION.

    Description of Event or Problem · 1

    THE REPORTER EXPERIENCED AN ISSUE WITH AN AQUARIUS MACHINE ALARMING, "AIR DETECTOR." TROUBLE SHOOTING WAS PROVIDED VIA PHONE AND THE USER WAS ADVISED TO REMOVE THE AQUASET AND START AGAIN. WHEN THE NURSE BEGAN REMOVING THE HEPARIN SYRINGE FROM THE SYRINGE DRIVER, IT WAS NOTED THAT FROM A STARTING POSITION OF 50MLS, THERE WAS ONLY 34MLS REMAINING. THE SYRINGE USED WAS A BD PLASTIPAK AND THE CONCENTRATION OF HEPARIN IN THE SYRINGE WAS 10,000 IN 50MLS. NO PATIENT INJURY WAS INITIALLY REPORTED WHICH WAS ALSO CONFIRMED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS AQUARIUS SYSTEM HEMOFILTRATION SYSTEM KDI EDWARDS LIFESCIENCES GEF09600

    Patients

    Seq Age Sex Outcome Treatment
    1