BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3589404 · Received January 23, 2014

    Report

    Report Number
    1061932-2014-00139
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    December 30, 2013
    Report Date
    December 30, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND INVESTIGATED THE ERRORS REPORTED AND FOUND VL211 (VALVE 211) LEAKED INTO THE INSTRUMENT CAUSING THE SOLENOID IS SHORTED ERROR. THE DILUENT FROM THE LEAK DAMAGED THE MRC (MODULE RESOURCE CONTROLLER) AND SCA (SIGNAL/CONDITIONER ANALYZER) BOARDS WHICH RESULTED IN THE MRC AND SCA ERRORS, AND LINE 8 ON THE FLOW CELL TUBING HARNESS TO POP OFF AND STOP OPERATION OF THE INSTRUMENT. DURING VERIFICATION, THE FSE REPLACED THE AMTC MODULE (AIR MIX TEMPERATURE CHAMBER) AND THE MTM (MULTI TRANSDUCER MODULE) WHILE TROUBLESHOOTING THE MULTIPLE ERRORS WHICH DID NOT RESOLVE THE ERRORS REPORTED. THE FSE THEN REPLACED THE MRC AND SCA BOARDS AND THE SOLENOID FOR VL211 TO RESOLVE THE ERRORS REPORTED. IDENTIFIED FAILURE MODES: THE FAILURE MODE IS THE FAILURE OF VALVE 211. NO ERRONEOUS RESULTS WERE GENERATED; THE FAILURE MODE IDENTIFIED FOR THE LEAK (VL211) IS LIKELY TO GENERATE ERRONEOUS RESULTS FOR DIFFERENTIAL AND RETICULOCYTE PARAMETERS DUE TO IMPROPER FLOWCELL CLEANING AFTER COUNT FOR ANALYSIS. UPON RECUR, THE FAILURE MODE IDENTIFIED FOR THE MRC AND SCA BOARDS IS NOT LIKELY TO GENERATE ERRONEOUS RESULTS FOR DIFFERENTIAL AND RETICULOCYTE PARAMETERS AS SOFTWARE EXCEPTION OCCURS AND INSTRUMENT HAS A FAILSAFE TO AVOID SAMPLE AND PATIENT MISMATCH ID ERRORS. EVALUATION OF PRODUCT LABELING: PER LABELING, BECKMAN COULTER INC URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IS NOT LIMITED TO PROTECTIVE EYEWEAR, GLOVES AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM GENERATED MULTIPLE ERRORS: SOLENOID IS SHORTED ERRORS, MRC (MODULE RESOURCE CONTROLLER) ERRORS, AND SCA (SIGNAL/CONDITIONER ANALYZER) ERRORS. THE INSTRUMENT WAS EVALUATED BY A BECKMAN COULTER FIELD SERVICE ENGINEER. THE FSE FOUND RESIDUE THAT APPEARED TO BE DRY DILUENT, BUT NO FLUID OR ACTIVE LEAK WAS OBSERVED. THE RESIDUE (VOLUME ESTIMATED TO BE 2 OZ) WAS CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING A LAB COAT, GLASSES AND GLOVES AT THE TIME OF THE INCIDENT. THERE WERE NO ARCS, SPARKS, FLAMES OR SMOKE GENERATED BY THE INSTRUMENT, ONLY THE ALARM WHICH INDICATED A SHORT WAS FOUND IN THE ELECTRICAL SYSTEM. THERE WAS NO EVIDENCE OF A SHORT INSIDE THE INSTRUMENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THERE WERE NO ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54047 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1