BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3911315 · Received July 2, 2014

    Report

    Report Number
    1061932-2014-01509
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE OBSERVED A LEAK FROM THE LOWER SHEATH RESTRICTOR TUBING NEAR THE DIFFERENTIAL MIX CHAMBER. THE FSE OBSERVED THE TUBING WAS DAMAGED FROM RUBBING ON DIFFERENTIAL MIX CHAMBER. THE FSE REPLACED THE TUBING TO RESOLVE THE LEAK ISSUE. THE FSE REPLACED THE RETIC TRANSFER PUMP AND THE PUMP CONNECTOR AFTER CONFIRMING THE FLUID LEAKED DAMAGED THE RETIC RANDOM ACCESS MEMORY (RAM) MODULE. THE FSE VERIFIED THE INSTRUMENT AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 20 MLS OF CLEAR FLUID LEAKED UNDERNEATH THE COULTER LH 750 HEMATOLOGY ANALYZER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTION EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE OCCURRENCE. THERE WAS NO REPORTED EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THE REPORTED EVENT. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385728 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1