BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2573594 · Received May 14, 2012

    Report

    Report Number
    1061932-2012-01635
    Event Type
    Malfunction
    Date Received
    May 14, 2012
    Date of Event
    April 19, 2012
    Report Date
    April 19, 2012
    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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER LABELING, BECKMAN COULTER INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS, SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2012. THE FSE STATED THAT THE LEAK WAS BELOW THE MANIFOLD #4 (MF4) AND QUICK DISCONNECT (QD4), BUT THERE WAS NO DEFINITE INDICATION THAT THE LEAK WAS A DIRECT CAUSE OF A FAULTY QD4. THE FSE RESEATED QD4 OF MF4 BECAUSE HE INSPECTED THE PORTS INSIDE THE QD AND DID NOT FIND ANY PROBLEMS OR DEFECTS. THE FSE DRIED UP THE LEAK BELOW THE INSTRUMENT (DIRECTLY BELOW QD4 AND MF4), AND RAN 2 STARTUPS AND QUALITY CONTROL (QC). THE FSE RETURNED THE NEXT DAY FOR A CHECKUP, BUT NO LEAKS WERE FOUND DURING THESE VISITS. MF4 AND QD4 DELIVER PRESSURIZED DILUENT OR CLEANING AGENT TO RINSE THE ASPIRATION PATHWAYS, AND THE DIFFERENTIAL MIXING, STAIN AND RETIC CHAMBERS. SINCE THE SOURCE OF THE LEAKING FLUID WAS NOT FOUND, IT COULD BE ANY CLEAR REAGENT USED IN THE INSTRUMENT WHICH INCLUDES: LH SERIES DILUENT, CBC LYSE (LYSE S III), LH SERIES DIFF PAK (ERYTHROLYSE II, STABILISE) OR LH SERIES RETIC PAK REAGENT B (RETIC CLEARING SOLUTION). THE LEAK WAS BELOW THE INSTRUMENT AND DID NOT SPILL ON ANY CRITICAL COMPONENT TO CAUSE ERRONEOUS RESULTS. THE CAUSE OF THE LEAK IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A CLEAR FLUID LEAK OF APPROXIMATELY 5ML DRIPPING FROM UNDER THE COULTER LH 750 HEMATOLOGY INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT AND GLOVES, WITH NO FACE PROTECTION. THERE WAS NO BIOHAZARD EXPOSURE TO ANYONE AND THERE WAS NO CONTACT TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THE CUSTOMER DID NOT NEED TO REVIEW THE MATERIAL SAFETY DATA SHEET (MSDS); HOWEVER, THEY ARE READILY AVAILABLE ON THE BECKMAN COULTER, INC. WEBSITE. THE FACILITY HAS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE. NO PATIENT RESULTS WERE AFFECTED AND NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS COMPLAINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1