BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ® LH750

    MDR report key: 2029095 · Received March 25, 2011

    Report

    Report Number
    1061932-2011-00187
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    THE TUBING CONNECTED TO THE RETIC CLEARING SOLUTION PUMP (MP6) CONTAINS RETIC CLEARING REAGENT (REAGENT B). A BCI FIELD SERVICE ENGINEER (FSE) REPLACED MP6 AND ASSOCIATED TUBING. A DEFINITIVE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THE TUBING CONNECTED TO THE TOP OF THE RETIC CLEARING SOLUTION PUMP (MP6) ON THE LH 750 INSTRUMENT KEEPS POPPING OFF AND LEAKING SOLUTION. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (LAB COAT AND GLOVES). NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS THE SPECIMENS WERE RERUN ON A BACKUP INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ® LH750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER INC. LH750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1