BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3031489 · Received April 2, 2013

    Report

    Report Number
    1061932-2013-00460
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE AND UPON INSPECTION CONFIRMED THAT THE WASTE VACUUM CHAMBER (VC222) WAS CRACKED NOT ALLOWING PROPER DRAINAGE OF THE BATHS CAUSING A LEAK. THE FSE REPLACED THE CRACKED VC222 CHAMBER WITH A NEW WASTE VACUUM CHAMBER WHICH RESOLVED THE ISSUE. THE CAUSE OF THE LEAK IS ATTRIBUTED TO A CRACKED WASTE VACUUM CHAMBER. IT IS UNKNOWN HOW THE WASTE VACUUM CHAMBER BECAME CRACKED. THERE HAS BEEN NO RECURRENCE OF THIS INCIDENT REPORTED BY THE CUSTOMER TO DATE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT THAT THE VC222 WASTE (VCS) CHAMBER ON THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM HAD CRACKED AT THE TOP OF THE CHAMBER. IT COULD NOT BE CONFIRMED IF THE INSTRUMENT GENERATED ANY ERROR MESSAGES OR FLAGS AS A RESULT OF THIS INCIDENT. THE CUSTOMER WAS WEARING GLOVES AT THE TIME OF THE INCIDENT. NO INJURY OR EXPOSURE WAS REPORTED. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134518 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER DXH 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1