BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2110106 · Received June 1, 2011

    Report

    Report Number
    1061932-2011-00523
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS PROVIDED AND THE FIELD SERVICE ENGINEER (FSE) INDICATED THAT MANIFOLD 4 CIRCUIT BOARD (RESPONSIBLE FOR PROBE RETRACTION) WAS REPLACED. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES AND THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE FOR THE REPORTED INCIDENT WAS ASSOCIATED WITH THE CIRCUIT BOARD FUNCTION RESPONSIBLE FOR PROBE RETRACTION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) AND REPORTED THAT THE MANUAL PROBE IN COULTER LH 750 HEMATOLOGY ANALYZER DID NOT RETRACT, AND THAT IT EJECTED 100 UL OF BLOOD WHEN THE ANALYZER WAS POWERED OFF. THE USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE INCIDENT. NO INJURIES OCCURRED AND THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE LAB'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED, BUT IT IS READILY AVAILABLE. THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. LH750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1