BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER ¿ COULTER ® LH 750 SLIDEMAKER

    MDR report key: 2526381 · Received April 11, 2012

    Report

    Report Number
    1061932-2012-01183
    Event Type
    Malfunction
    Date Received
    April 11, 2012
    Date of Event
    March 12, 2012
    Report Date
    March 12, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKJ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    ROOT CAUSE FOR THE EVENT IS DUE PINCH TUBING CUT DUE TO WEAR AT THE PINCH POINT. (B)(4).

    Description of Event or Problem · 1

    (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SMALL AMOUNT OF PINK-TINGED FLUID FROM BECKMAN COULTER LH 750 SLIDEMAKER INSTRUMENT ONTO THE FLOOR AND THE TABLE. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT AND THE SOURCE OF THE LEAK WAS UNKNOWN. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, EYE PROTECTION, AND GLOVES. THE CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID AND DID NOT SEEK MEDICAL ATTENTION. NO EXPOSURE (SPRAYED OR SPLASHED) TO MUCOUS MEMBRANES OR OPEN WOUNDS WERE REPORTED. NO DEATH, INJURY OR CHANGES TO PATIENT TREATMENT OR RESULTS ARE ASSOCIATED WITH THIS EVENT. THE FACILITY DOES HAVE A RISK MANAGEMENT / EXPOSURE CONTROL PLAN IS IN PLACE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE EVENT. UPON ARRIVAL THE FSE STATED THE UNIT WAS TURNED OFF AND NO LEAKS WERE FOUND. THE LEAK HAD NOT BEEN CONTAINED WITHIN THE UNIT; THE CUSTOMER HAD CLEANED FLUID FROM THE TABLE. THE DRIP TRAY IN THE UNIT WAS FULL OF FLUID; APPROXIMATELY 8 OZ. A PIECE OF BLACK STRIPE NC TUBING THROUGH PV19 WAS LEAKING DUE TO WEAR AT THE PINCH POINT. THE TUBING SUPPLIED DILUENT/CLENZ/BLEACH UNDER PRESSURE. NO OTHER PARTS WERE LEAKING. THE UNIT WAS PERFORMING WITHIN SPECIFICATIONS AFTER THE SERVICE. THE LINE SUPPLIED DILUENT, CLENZ AND BLEACH; THE SOLUTION ALSO MIXED WITH DRIED SOLUTION FROM PREVIOUS LEAKS. THE FIELD SERVICE ENGINEER (FSE) CLEANED THE UNIT AND REPLACED BLACK STRIPE TUBING CUT AT PINCH VALVE PV19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER ¿ COULTER ® LH 750 SLIDEMAKER SPINNER, SLIDE, AUTOMATED GKJ BECKMAN COULTER INC. LH750 SM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1