BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER PK7300 AUTOMATED MICROPLATE SYSTEM

    MDR report key: 3662029 · Received March 5, 2014

    Report

    Report Number
    9612296-2014-00044
    Event Type
    Malfunction
    Date Received
    March 5, 2014
    Date of Event
    February 19, 2014
    Report Date
    February 20, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    KSZ
    PMA / PMN Number
    BK090036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INITIAL REPORTER INFORMATION FROM SECTION E1 OF THIS REPORT: THE CUSTOMER'S TELEPHONE NUMBER IS 44-0161-251 4206. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE EVALUATED THE INSTRUMENT AND DETERMINED THAT THE CAUSE OF THE LEAK IS ATTRIBUTED TO A DEFECTIVE DETERGENT PUMP. THE FSE REPLACED THE DETERGENT PUMP TO RESOLVE THE ISSUE AND VERIFIED THE REPAIR AS PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DILUTED DETERGENT LEAKED FROM THE BECKMAN COULTER PK7300 AUTOMATED MICROPLATE SYSTEM. THE CUSTOMER DID NOT SPECIFY THE VOLUME OF THE LEAK, BUT INDICATED THAT THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT AND DILUTED DETERGENT LEAKED ONTO THE FLOOR OF THE LABORATORY. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF THE EVENT AND NO INJURY OR DIRECT EXPOSURE TO THE LEAK WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132330 BECKMAN COULTER PK7300 AUTOMATED MICROPLATE SYSTEM SYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY KSZ BECKMAN COULTER PK7312-03 NA

    Patients

    Seq Age Sex Outcome Treatment
    1