BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2223710 · Received August 25, 2011

    Report

    Report Number
    1061932-2011-01303
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT IT HAD BEEN ONGOING ISSUE FOR SEVERAL MONTHS. SIMILAR EVENT ON (B)(6) 2011, WAS REPORTED IN A SEPARATE REPORT #1061932-2011-00913. BEC CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER TO MAKE SURE PPE IS WORN WHILE WORKING ON THE INSTRUMENT. ON (B)(4) 2011, BEC FIELD SERVICE ENGINEER (FSE) TESTED THE INSTRUMENT DURING HIS VISIT BY RUNNING RACKS OF BLOODS. HOWEVER, THERE WAS NO EVIDENCE OF BLOOD PRESENT ON THE STRIPPER PLATE AT THIS TIME WHILE RUNNING THE INSTRUMENT. THE CUSTOMER STATED THAT AFTER THE UNIT HAS BEEN RUNNING FOR A PERIOD OF 12 HOURS OR MORE (LATE AT NIGHT) SMALL BLOOD RESIDUE IS SEEN ON THE STRIPPER PLATE AFTER THE NEEDLE HAS PIERCED THE TUBE(S). HOWEVER, THE ISSUE COULD NOT BE REPRODUCED. THIS IS AN OLD UNIT AND WILL BE REPLACED WITHIN 30 DAYS. THE ROOT CAUSE COULD NOT BE DETERMINED BASED ON AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT BLOOD HAD BEEN SPITTING ONTO STRIPPER PLATE DURING COULTER LH 750 HEMATOLOGY ANALYZER OPERATION. THE CUSTOMER WAS WEARING PROPER PPE INCLUDING GLOVES, A LAB COAT, AND GOGGLES AT THE TIME OF THE EVENT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANE OR OPEN WOUNDS. NO ONE REQUIRED MEDICAL ATTENTION. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS INCIDENT. MSDS WAS NOT REVIEWED, BUT THERE IS AN EXPOSURE CONTROL OR RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1