BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 3864539 · Received June 10, 2014

    Report

    Report Number
    2432235-2014-00371
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MOI
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE DETERMINED THAT THE SMOKE WAS EMITTED FROM THE ALTERNATING CURRENT (AC) POWER RECEPTACLE. THE CSE DETERMINED THAT A BLOCKAGE IN THE DRAIN LINE ALLOWED WATER TO OVERFLOW FROM THE REAGENT COMPARTMENT, WHICH CAME IN CONTACT WITH THE POWER RECEPTACLE. THE CAUSE OF THE SMOKE BEING EMITTED FROM THE INSTRUMENT WAS DUE TO WATER CONTACTING THE AC POWER RECEPTACLE. THE CSE REPLACED THE POWER RECEPTACLE AND VERIFIED PROPER FUNCTIONING OF THE DRAIN PINCH VALVES. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE OPERATOR OF AN ADVIA CENTAUR XP INSTRUMENT OBSERVED SMOKE BEING EMITTED FROM THE INSTRUMENT. THE LABORATORY WAS NOT EVACUATED. THE INSTRUMENT WAS POWERED DOWN BY THE CUSTOMER. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE SMOKE EMITTED FROM THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340884 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER MOI SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1