BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELLTRACKS AUTOPREP SYSTEM

    MDR report key: 1342099 · Received March 11, 2009

    Report

    Report Number
    3004582358-2009-00001
    Event Type
    Other
    Date Received
    March 11, 2009
    Date of Event
    February 20, 2009
    Report Date
    February 26, 2009
    Manufacturer
    VERIDEX, LLC
    Product Code
    GKH
    PMA / PMN Number
    K040077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE WASTE BOTTLE IS USED WITH THE CELLTRACKS AUTOPREP SYSTEM TO COLLECT THE LIQUID WASTE (HUMAN BLOOD, DILUTION BUFFER AND REAGENTS) GENERATED DURING THE CELLTRACKS SAMPLE PREPARATION PROCEDURE. A 400ML OF CLOROX BLEACH IS ADDED TO THE BOTTLE TO DECONTAMINATE THE LIQUID WASTE GENERATED DURING THE CELLTRACKS AUTOPREP PROCEDURE. THE BLEACH IS ADDED TO THE BOTTLE AFTER IT IS EMPTIED, AND PRIOR TO THE LIQUID WASTE BEING EMPTIED INTO THE WASTE BOTTLE FROM THE INSTRUMENT. THE HUMAN BLOOD CONSISTS MAINLY OF PLASMA. THE VERIDEX EMPLOYEE INDICATED THAT THE CELLTRACKS AUTOPREP SYSTEM WASTE BOTTLES ARE USED INTERCHANGEABLY AMONG THE 5 SYSTEMS INSTALLED AT THEIR SITE. THERE IS ONE WASTE BOTTLE FOR EACH INSTRUMENT. THE EMPLOYEE DOES NOT REMEMBER WHICH INSTRUMENT THE WASTE BOTTLE WAS ASSOCIATED WITH AT THE TIME THE EVENT OCCURRED. THE OLDEST AUTOPREP SYSTEM INSTALLED AT THIS VERIDEX SITE WAS SHIPPED TO THE SITE IN 2003. THE VERIDEX EMPLOYEE VISITED HIS DR THE SAME DAY THE EVENT OCCURRED AND RECEIVED AN (B)(6) AND (B)(6) AS A PREVENTIVE MEASURE. THE EMPLOYEE HAS NOT EXPERIENCED ANY SKIN IRRITATION, VOMITING OR DIZZINESS AND HAS NOT EXPERIENCED ANY HEALTH ISSUES SINCE THE EVENT OCCURRED. THE WASTE BOTTLE INVOLVED IN THIS EVENT HAS BEEN RETURNED TO VERIDEX LLC, (B)(4), AND A FAILURE INVESTIGATION IS UNDERWAY. IN ADDITION, A CUSTOMER LETTER IS BEING SENT TO ALL CUSTOMERS. THIS LETTER INSTRUCTS CUSTOMERS TO INSPECT THE BOTTLES ON THEIR CELLTRACKS AUTOPREP SYSTEM DURING THE DAILY CLEANING PROCEDURE AND TO NOT USE CRACKED OR DAMAGED WASTE BOTTLES. VERIDEX WILL REPLACE CRACKED OR DAMAGED BOTTLES.

    Description of Event or Problem · 1

    A VERIDEX EMPLOYEE INDICATED THAT WHEN INVERTING A CELLTRACKS AUTOPREP SYSTEM WASTE BOTTLE TO EMPTY IT IN THE SINK, THE WASTE BOTTLE RUPTURED AND THE WASTE AND BLEACH SPRAYED ALL OVER HIS LAB COAT AND HIS FACE. THE EMPLOYEE WAS WEARING GOGGLES AND DID NOT GET ANY LIQUID INTO HIS EYES, HOWEVER, SOME LIQUID DID ENTER HIS MOUTH. THE WASTE BOTTLE CONTAINED HUMAN BLOOD, DILUTION BUFFER, REAGENTS AND CLOROX BLEACH. THE TOTAL VOLUME OF LIQUID WASTE WAS APPROXIMATELY 4 LITRES AND THE CAPACITY OF THE WASTE BOTTLE IS 5 LITRES. APPROXIMATELY 0.5L OF THE WASTE MATERIAL PROJECTED ONTO THE VERIDEX EMPLOYEE. THE VERIDEX EMPLOYEE SOUGHT MEDICAL ATTENTION THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELLTRACKS AUTOPREP SYSTEM CELLTRACKS AUTOPREP SYSTEM GKH VERIDEX, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA