BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMA AUTOMATED BLOOD COLLECTION SYSTEM

    MDR report key: 1972822 · Received January 14, 2011

    Report

    Report Number
    1722028-2010-00155
    Date Received
    January 14, 2011
    Date of Event
    October 8, 2010
    Report Date
    January 14, 2011
    Manufacturer
    CARIDIAN
    Product Code
    LKN
    PMA / PMN Number
    BK030083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RDF ANALYSIS WAS PERFORMED FOR ALL THREE OF THE DONORS AND THE PROCEDURES REPORTED TO HAVE HAD REACTIONS. IN ALL CASES BUT ONE, THERE WERE NO INDICATIONS OF ISSUES WITH THE PROCEDURE AND THE EQUIPMENT OPERATED AS INTENDED. IN ONE CASE, THE DONOR PARAMETERS WERE ENTERED INCORRECTLY, HOWEVER, RDF ANALYSIS CONFIRMS THAT ONLY 14MLS OF EXTRA VOLUME WAS TAKEN. FURTHER, ANALYSIS WAS PERFORMED USING ALL RDFS WE HAVE FOR (B)(6) TO DETERMINE IF THERE HAVE BEEN ANY PROCESS CHANGES THAT COULD HAVE CONTRIBUTED TO THESE REACTIONS. A BIT LESS THAN 25% OF ALL DONORS RUN AT (B)(6) HAVE 14-15% OF THEIR BLOOD TAKEN/TBV. THERE DOES SEEM TO BE A SLIGHT UPWARD TREND IN THE % BLOOD GIVEN/TBV WHEN SEEN OVER THE LAST 12 MONTH PERIOD. NO OTHER TRENDS OR PATTERNS WERE NOTED THAT COULD BE CONTRIBUTING FACTORS TO THESE REACTIONS. IN THE LAST 24 MONTH PERIOD, THERE WAS ONLY ONE OTHER REPORTED PT REACTION FROM A PROCEDURE WHICH WAS NOT RELATED TO AN AMAP PLASMA PROCEDURE, AS SEEN USING A WARP REPORT FOR FAILURE CODE. THE DHR WAS REVIEWED FOR BOTH (B)(4) AND NO PROBLEMS WERE FOUND. CONCLUSION: THIS TYPE OF REACTION IS ANTICIPATED FOR DONORS, BUT THE OUTCOME IS USUALLY NOT THIS SEVERE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED FOR CLARIFICATION. THE INCIDENT WAS ORIGINALLY INCLUDED IN MDR 1722028-2010-00126, BUT IS BEING REPORTED SEPARATELY FOR CLARITY. A (B)(6) MALE AND FIRST TIME DONOR REPORTEDLY FELT FINE AFTER THE DONATION AND STAYED AT THE CENTER FOR 10 MINUTES AND DRANK WATER. WHILE DRIVING HOME, THE DONOR BEGAN TO FEEL ILL, HE PULLED OVER AND VOMITED ABOUT SIX TIMES. THE COMPLAINANT WAS UNWILLING TO PROVIDE DONOR ID INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA AUTOMATED BLOOD COLLECTION SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIAN 017000000

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other