BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 SLIDEMAKER

    MDR report key: 2609627 · Received June 11, 2012

    Report

    Report Number
    1061932-2012-01759
    Event Type
    Malfunction
    Date Received
    June 11, 2012
    Date of Event
    May 14, 2012
    Report Date
    May 14, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKJ
    PMA / PMN Number
    CLASS1EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE THE DAY OF THE EVENT AND FOUND A HOLE IN THE TUBING THROUGH PINCH VALVE VL1 ON THE SLIDEMAKER SAMPLE ACCESS MODULE (SAM), WHICH IS HOUSED UNDER THE COVER OF THE LH 750 ANALYTIC STATION. FSE REPLACED THE TUBING WHICH RESOLVED THE LEAK. DURING THIS SERVICE, FSE INADVERTENTLY TOUCHED THE TUBING THROUGH THE ADJACENT PINCH VALVE VL2 AND THE LINE POPPED OFF. JUST AFTER THE FSE LEFT, THE CUSTOMER REPORTED THE SUBSEQUENT LEAK; THE FSE WAS PAGED AND RETURNED THE SAME DAY TO REPAIR THE LEAK. THE CAUSE OF THE LEAK WAS A HOLE IN TUBING AND THE SUBSEQUENT LEAK WAS CAUSED BECAUSE TUBING POPPED OFF DUE TO FSE ERROR. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT CLEAR LIQUID WAS LEAKING FROM THE TUBING CONNECTING THE COULTER LH 750 HEMATOLOGY ANALYZER TO THEIR COULTER LH 750 SLIDEMAKER. A FEW DROPS (APPROXIMATELY 0.05 CC OF THE FLUID WAS ON THE COUNTER BETWEEN THE INSTRUMENTS. IN ADDITION, A FEW DROPS APPROXIMATELY 0.2 CC) WAS OBSERVED UNDER THE LASER. THE SLIDEMAKER STOPPED MAKING SLIDES DURING LEAK AND THE LEAK CEASED WHEN THE OPERATOR DISABLED THE SOFTWARE CONNECTION TO THE SLIDEMAKER. THERE IS AN EXPOSURE CONTROL PLAN IN PLACE AT THE FACILITY. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT. NO INJURY OR EXPOSURE WAS REPORTED. THERE WAS NO IMPACT TO PATIENT SAMPLES OR RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 SLIDEMAKER AUTOMATED SLIDE SPINNER GKJ BECKMAN COULTER INC. LH 750 SLIDEMAKER NA

    Patients

    Seq Age Sex Outcome Treatment
    1