BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX ®20 PRO SYSTEM

    MDR report key: 2821796 · Received November 6, 2012

    Report

    Report Number
    2050012-2012-01797
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEIR SYNCHRON LX 20 PRO SYSTEM LEAKED A YELLOW FLUID ONTO THE FLOOR FROM THE MODULAR CHEMISTRY SIDE. THE CUSTOMER SUSPECTED THE SPILL TO BE CREATININE REAGENT. THE CUSTOMER PLACED A TOWEL ON THE LEAK TO CONTAIN. THE CUSTOMER STOPPED USING THE INSTRUMENT AND THE LEAK HAD STOPPED. 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. ON (B)(4) 2012, FIELD SERVICE ENGINEER WAS ON SITE AND NOTED A DAMAGED PUMP. THE FSE REPLACED THE PUMP AND THE TRICONTINENT SYRINGE. THE FAILURE MODE OF THE EVENT WAS THE DAMAGED TRICONTINENT SYRINGE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX ®20 PRO SYSTEM ELECTRODE, ION SPECIFIC, SODIUM JGS BECKMAN COULTER, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1