BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX CAP PIERCE HEMATOLOGY ANALYZER

    MDR report key: 2942486 · Received February 4, 2013

    Report

    Report Number
    1061932-2013-00136
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) ASSISTED THE CUSTOMER TROUBLESHOOT THE LEAK OVER THE PHONE. PER THE CUSTOMER, THE LEAK WAS CAUSED BY A HOLE IN THE TUBING AT THE TRIPLE PINCH VALVE BELOW THE VACUUM TRAP JAR. THE TRIPLE PINCH VALVE BELOW THE VACUUM TRAP JAR IS PINCH VALVE PV49. THE PV49 PROVIDES OPEN PATH FOR VACUUM AND DILUENT TO THE BACKWASH PUMP, PM8, AND ALSO PROVIDES AN OPEN VACUUM PATH FROM PROBE WIPER TO THE DIFFERENTIAL WASTE CHAMBER, VC7. FLUIDS ASSOCIATED WITH THIS EVENT WERE: DILUENT, BLOOD AND CLENZ. THE CUSTOMER REPLACED ALL OF THE TUBING THROUGH THE PINCH VALVE PV49 AND THE LEAK WAS FIXED. PER A CONVERSATION WITH THE FSE, THE CUSTOMER RAN THE INSTRUMENT AND VERIFIED THAT THE LEAK WAS FIXED. THE CAUSE OF THE LEAK WAS A HOLE IN THE TUBING THROUGH PINCH VALVE PV49. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A LEAK AT THE VACUUM TRAP AREA OF THE COULTER HMX CAP PIERCE HEMATOLOGY ANALYZER. THE VOLUME OF THE LEAK WAS NOT SPECIFIED AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THE LAB'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE EVENT. NO ONE CAME IN CONTACT WITH THE FLUID. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47118 COULTER® HMX CAP PIERCE HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER N/A

    Patients

    Seq Age Sex Outcome Treatment
    1