BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTUAR XP SYSTEM

    MDR report key: 7281084 · Received February 19, 2018

    Report

    Report Number
    2432235-2018-00071
    Event Type
    Malfunction
    Date Received
    February 19, 2018
    Date of Event
    January 23, 2018
    Report Date
    March 12, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414573564
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR 2432235-2018-00071 WAS FILED 19-FEB-2018. SIEMENS HEALTHCARE DIAGNOSTICS INC. (B)(4).

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE SITE TO INVESTIGATE THE BURNING SMELL. THE CSE FOUND THAT THE WASH 1 RESERVOIR HAD LEAKED ONTO THE GLOBAL INPUT OUTPUT BOARD (GIOB) CAUSING THE BOARD TO FAIL. THE GIOB WAS REPLACED. THE ACID PUMP, BASE PUMP AND ASSOCIATED CABLES WERE ALSO FOUND TO BE DAMAGED AND WERE REPLACED. THE CSE RETURNED THE SYSTEM TO AN OPERATIONAL STATUS. THE CAUSE OF THE BURNING SMELL WAS THE GIOB FAILURE DUE TO A FLUID LEAK FROM THE WASH 1 RESERVOIR. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BURNING SMELL WAS BEING EMITTED FROM THE ADVIA CENTAUR XP SYSTEM. THE CUSTOMER TURNED OFF THE SYSTEM. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE BURNING SMELL BEING EMITTED BY THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123268 ADVIA CENTUAR XP SYSTEM ADVIA CENTUAR XP SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. 00630414573564

    Patients

    Seq Age Sex Outcome Treatment
    1