BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUARIUS

    MDR report key: 1930915 · Received December 16, 2010

    Report

    Report Number
    1423500-2010-06976
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 22, 2010
    Manufacturer
    NIKKISO MEDICAL SYSTEMS GMBH
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. A BAXTER FIELD ENGINEER VISITED THE HOSPITAL TO CHECK THE MACHINE FOR ANY MALFUNCTIONS. ALL CALIBRATION VALUES WERE CHECKED, THE MACHINE LINED, PRIMED AND TREATMENT RAN WITHOUT ALARMS OR ISSUES. NO FAULT WAS FOUND. THE MACHINE WORKED WITHIN ITS SPECIFICATIONS AND WAS RELEASED FOR SERVICE. AS THE MACHINE ALARMED AND NO FAILURE WAS FOUND DURING TECHNICAL INSPECTION THE EXACT ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED BY BAXTER. IT WAS REPORTED THAT ON AN UNCONFIRMED DATE AN AQUARIUS MACHINE WAS INVOLVED IN A CHECK DE-GAS CHAMBER ALARM INCIDENT. AT THE TIME OF THE PROBLEM IT WAS REPORTED THAT THE MACHINE WAS SET UP AND READY TO USE. THE MACHINE STARTED PRIMING OK. ONCE PRIMED AND READY TO USE, IT KEPT ALARMING CHECK DE-GAS CHAMBER. THE OPERATOR WAS UNABLE TO RECTIFY THEREFORE CALLED FOR ASSISTANCE FROM DIALYSIS TECHNICIAN. THE DIALYSIS TECH SEEMED TO SORT THE PROBLEM AND THEREFORE CONNECTED PATIENT TO MACHINE. THE MACHINE SEEMED TO WORK OK INITIALLY, AND THEN AIR BUBBLES STARTED APPEARING. THE CIRCUIT HAD AIR INSIDE. THE DIALYSIS TECHNICIAN CALLED AGAIN, AND THE PATIENT DISCONNECTED FROM MACHINE. THE MACHINE WAS TAKEN BY DIALYSIS TECHNICIAN FOR TESTING. THE DEVICE WAS EVALUATED ONSITE BY A BAXTER FIELD SERVICE ENGINEER (FSE). THE FSE STATED THAT NO FAULT COULD BE FOUND WITH THE UNIT. NO CONSEQUENCES FOR THE PATIENT WERE REPORTED. THE MACHINE WAS CHECKED BY A BAXTER TECHNICIAN, AND THE MACHINE IS STILL IN USE AT THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUARIUS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIKKISO MEDICAL SYSTEMS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1