BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUARIUS

    MDR report key: 2200234 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10524
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 28, 2011
    Manufacturer
    NIKKISO MEDICAL SYSTEMS GMBH
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    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 SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. IF THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED TO BAXTER (B)(4) THAT BEFORE USE OF THE MACHINE A BURNING SMELL WAS NOTICED BY THE NURSE. A BURNED ELECTRONIC COMPONENT WAS VISIBLE ON THE SECONDARY POWER SUPPLY. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION AS THIS WAS BEFORE PATIENT USE.

    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