BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750 HEMATOLOGY ANALYZER

    MDR report key: 2403062 · Received January 7, 2012

    Report

    Report Number
    1061932-2012-00055
    Event Type
    Malfunction
    Date Received
    January 7, 2012
    Date of Event
    December 7, 2011
    Report Date
    December 7, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE FOR THE LEAK WAS A DETACHED PROBE WASH BLOCK, WHICH WAS RESOLVED WITH THE TROUBLESHOOTING DESCRIBED. (NOTE: THE BECKMAN COULTER, INC. IDENTIFIER FOR THIS REPORT IS (B)(4).)

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE PROBE WASH BLOCK CAME OFF THE AIR CYLINDER OF THE COULTER LH750 HEMATOLOGY ANALYZER, CAUSING A WASTE LEAK. CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, EYE PROTECTION, AND GLOVES. CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID. MEDICAL ATTENTION WAS NOT SOUGHT AND THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ONE WAS SPLASHED OR SPRAYED. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS COMPLAINT, NOR WAS THERE IMPACT TO PATIENT RESULTS AS A RESULT OF THIS EVENT. THE CUSTOMER TECHNICAL SPECIALIST (CTS) ASSISTED CUSTOMER WITH RESOLVING THE ISSUE VIA TELEPHONE. THE CTS WAS ABLE TO DETERMINE THAT THE PROBE WASH BLOCK HAD COME OFF THE AIR CYLINDER. CUSTOMER WAS THEN ABLE TO REINSTALL THE PROBE LEAK WITH THE GUIDANCE OF THE CTS. THERE WAS NO FURTHER EVIDENCE OF LEAKING. THERE HAVE BEEN NO REPORTS OF RECURRENCE BY CUSTOMER TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1