BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 4586840 · Received March 10, 2015

    Report

    Report Number
    2432235-2015-00119
    Event Type
    Malfunction
    Date Received
    March 10, 2015
    Date of Event
    July 21, 2014
    Report Date
    October 3, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Removal / Correction Number
    2432235-10202014-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE ACID AND BASE RESERVOIR TUBING WAS REPLACED. SIEMENS HEALTHCARE DIAGNOSTICS IS CONDUCTING A FIELD CORRECTIVE ACTION FOR THE ADVIA CENTAUR AND ADVIA CENTAUR XP IMMUNOASSAY SYSTEMS, FLUID RESERVOIR CONNECTOR TUBING. THE TUBING FOR THE WASH 1, ACID, AND BASE BOTTLE RESERVOIRS MAY BE AFFECTED. SIEMENS HAS DETERMINED THAT ON SOME SYSTEMS A SLIGHT CRACKING OF THE TUBING AT THE CONNECTING FITTING ON THE RESERVOIR CONNECTOR ASSEMBLY MAY OCCUR DUE TO MECHANICAL STRESS. THE CRACKING MAY RESULT IN A MINOR DRIP OF FLUID ONTO THE RESERVOIR AND INTO THE DRIP TRAY LOCATED UNDERNEATH THE RESERVOIRS. THE POTENTIAL FOR MINIMAL FLUID LEAKAGE OUTSIDE THE SYSTEM EXISTS. THE DRIP WILL CAUSE THE RESERVOIR TO EMPTY FASTER THAN THE SYSTEM EXPECTS. WHEN THE FLUID IN THE RESERVOIR IS EMPTY, SAMPLES PROCESSED MAY NOT HAVE THE CORRECT VOLUME OF ACID OR BASE FLUID DISPENSED FOR THE REACTION. ONCE THE ACID AND BASE FLUIDS ARE DEPLETED, THE SYSTEM DETECTS IT AND WILL FLAG ALL SUBSEQUENT RESULTS WITH A SIGNAL ERROR FLAG. WHEN WASH 1 FLUID BECOMES LOW, THE SYSTEM WILL DETECT IT AND STOP PROCESSING SAMPLES. IF THE TUBING IS CRACKED AND LEAKING, AND THE USER DOES NOT REPLACE THE FLUID BOTTLES ON THE YELLOW SYSTEM ALERT AND THE RESERVOIR BECOMES EMPTY, THE SYSTEM WILL FLAG RESULTS WITH A SIGNAL ERROR ONCE THE LACK OF ACID/BASE SOLUTION IS DETECTED. IN THIS CASE, A LIMITED NUMBER OF TEST RESULTS (UP TO 20 TESTS) PROCESSED PRIOR TO A SIGNAL ERROR MAY BE AFFECTED AND NOT FLAGGED; HOWEVER, SUBSEQUENT MULTIPLE SIGNAL ERRORS WOULD INDICATE THAT A SYSTEM MALFUNCTION HAS OCCURRED AND THAT RESULTS NEED TO BE CHECKED. URGENT MEDICAL DEVICE CORRECTION (UMDC) 10819180 WAS SENT TO CUSTOMERS IN THE UNITED STATES IN OCTOBER 2014 AND URGENT FIELD SAFETY NOTICE (UFSN) 10819179 WAS SENT TO CUSTOMERS OUTSIDE THE UNITED STATES IN OCTOBER 2014. THE UMDC AND UFSN DESCRIBE THE ISSUE AND PROVIDE ACTIONS TO BE TAKEN BY THE CUSTOMER TO MITIGATE THE POSSIBILITY OF IMPROPER FLUID DISPENSES.

    Description of Event or Problem · 1

    TUBING FOR THE ACID AND BASE RESERVOIRS OF AN ADVIA CENTAUR XP INSTRUMENT SPLIT OPEN, CAUSING THE FLUIDS TO LEAK. THERE WAS NO IMPACT TO PATIENT SAMPLE RESULTS AND NO OPERATORS EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE LEAKING FLUIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165330 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1