BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® PREPPLUS

    MDR report key: 2242086 · Received September 9, 2011

    Report

    Report Number
    1061932-2011-01399
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN TUBES IN QUESTION ARE FROM BD BUT ARE NOT ON THE LIST IN THE BEC LABELING. IF SO, THE CUSTOMERS ARE INSTRUCTED TO VALIDATE THE TUBE FOR THEIR USE. THE INSTRUMENT DID NOT SHOW ANY ERROR MESSAGE. FIELD SERVICE ENGINEER (FSE) CHECKED THE PREPPLUS AND TESTED DIFFERENT TUBES. THE INSTRUMENT WORKED WITHOUT ANY TECHNICAL PROBLEMS. THE ROOT CAUSE FOR THE EVENT WAS THAT THE CUSTOMER USED SAMPLE TUBES THAT WERE NOT VALIDATED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED ABOUT THE COULTER PREPPLUS MAKING BLOOD DROPS AND SPLASHES IN FRONT OF THE INSTRUMENT. THIS ONLY OCCURS WHEN USING BD VACUTAINER (B)(4) (LITHIUM-HEPARIN) AND (B)(4) (SODIUM -HEPARIN) NOT WITH TERUMO VENOSAFE TUBES (B)(4). THE CUSTOMER CLEANED THE INSTRUMENT WITH SURFACE DISINFECTANT (BLEACH SOLUTION). THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), AND THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION. THERE WAS NO DEATH OR INJURY AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® PREPPLUS STATION, PIPETTING AND DILUTING, FOR CLINICAL USE JQW BECKMAN COULTER, INC. PREPPLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1