BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS AQUARIUS SYSTEM

    MDR report key: 1760155 · Received July 16, 2010

    Report

    Report Number
    2015691-2010-13717
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 25, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KDI
    PMA / PMN Number
    K070320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE DEVICE IS PERFORMED IN-SITU (CONFLICTING INFORMATION REGARDING THE DEVICE EVALUATION - WHETHER THE DEVICE IS/IS NOT AVAILABLE FOR EVALUATION). THE APPROVED EVALUATION WAS NOT PROVIDED AT THE TIME OF THIS SUBMISSION, ALTHOUGH THE INITIAL REPORT STATES: "MACHINE CHECKED-NO FAULT FOUND-STILL IN USE AT THE UNIT." THEREFORE, IF AVAILABLE, EVALUATION FOR METHOD, RESULTS AND CONCLUSION WILL BE PROVIDED IN A FOLLOW UP SUBMISSION. THE DEVICE WAS MANUFACTURED IN 2007. THE DEVICE HISTORY RECORD REVIEW INDICATES THAT THE DEVICE WAS UPDATED DURING START UP AND ADJUSTMENT. THE DEVICE WAS EQUIPPED WITH THE CURRENT VERSION OF PRESSURE SENSORS AND THE FOLLOWING COMPONENTS WERE UPDATED: (B)(4). THE DEVICE FULFILLED ALL RELEASE REQUIREMENTS DURING FINAL INSPECTION. THE DHR INCLUDES DATA FROM THE PRODUCTION OF THE DEVICE WHICH WAS PRODUCED MORE THAN 2 YEARS AGO. THE CONTRACT MANUFACTURER HAS NO INFORMATION RELATED TO INSTALLATION, UPGRADES, MODIFICATIONS, MAINTENANCES AND OTHER SERVICE ACTIVITIES AND THE DEVICE WAS MAINTAINED ONCE PER YEAR AT A MINIMUM. AFTER FINAL INSPECTION THE DEVICE WAS EQUIPPED WITH AN ADDITIONAL PREFILTER PRESSURE SENSOR CLAMP IN ACCORDANCE WITH THE BULLETIN NR.111 REV.A.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED BY BAXTER (B)(4) ON (B)(6) 2010 FROM (B)(6) HOSPITAL VIA THE ACCOUNT MANAGER. REPORTEDLY, ON (B)(6) 2010, AN AQUARIUS GEF09600, SERIAL NUMBER (B)(4) WAS INVOLVED IN AN ALLEGED OVER INFUSION. THE NURSE REPORTED THAT THE TREATMENT BEGAN AT 03:00 HRS (B)(6) 2010; THE PROGRAMMED HEPARIN RATE WAS 5MLS/HR. AT 09:00 HRS ON (B)(6) 2010, THE NURSE OBSERVED THAT THE SYRINGE HAD INFUSED 15MLS HAD INTO THE PATIENT DURING THE PREVIOUS HOUR. THE NURSES RECORD FLUID CHANGES HOURLY AND THIS QUANTITY WAS NOTED DURING THE HOURLY CHECK. THE NURSE STATED; "MACHINE DID NOT GIVE ANY ALARMS." THE REPORTED PROBLEM WAS DESCRIBED AS "MACHINE DID NOT ALARM-INCORRECT FLOW RATE." THE TREATMENT WAS STOPPED AND AN ACTIVATED PARTIAL THROMBOPLASTIN TIME RATIO (APTTR) WAS TAKEN. THE NURSE REPORTED THAT THE APTTR WAS 1.5 AND THE PATIENT DID NOT DISPLAY ANY OBVIOUS SIDE EFFECTS. THE CONCENTRATION OF THE HEPARIN SYRINGE WAS 5000 IU IN 50MLS. THERE WAS NO PATIENT/USER/OTHER PERSON'S INJURY REPORTED AT TIME OF LOGGING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE INITIAL REPORT STATES "MACHINE CHECKED-NO FAULT FOUND-STILL IN USE AT THE UNIT." THIS IS THE ONLY INFORMATION AVAILABLE AT TIME OF LOGGING. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1