BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

    MDR report key: 2222074 · Received August 16, 2011

    Report

    Report Number
    1722028-2011-00281
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    March 31, 2011
    Report Date
    July 21, 2011
    Manufacturer
    CARDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK040086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THERE WAS NO INTERNAL PART EVAL SINCE THERE WAS NO PART REPLACED IN THE FIELD OR RETURNED TO CARDIANBCT. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MFG THAT WERE RELEVANT TO THIS ISSUE. THE RUN DATA FILE WAS ANALYZED FOR THE PREVIOUS DONATION ON (B)(6) 2011. IT WAS DISCOVERED THAT THE OPERATOR FALSELY INCREASED THE DONOR'S HEMATOCRIT TO 41% WHICH MADE HIM ELIGIBLE TO DONATE A DRBC. THE TRIMA ACCEL SYSTEM OPERATED AS INTENDED. ROOT CAUSE: OPERATOR ERROR. CORRECTIVE/PREVENTIVE ACTION: A REPORT OF OPERATOR ERROR TRENDS IS DISTRIBUTED QUARTERLY TO THE SALES AND IMPLEMENTATION TEAMS TO DETERMINE THE NEEDS FOR TARGETED TRAINING OPPORTUNITIES.

    Description of Event or Problem · 1

    THE CUSTOMER WANTED TO KNOW WHY THE DONOR WAS NOT ELIGIBLE TO DONATE A DOUBLE RED CELL PRODUCT ON (B)(6) 2011, WHEN HE WAS ABLE TO DO SO ON A PREVIOUS DONATION ON (B)(6) 2011. NO MEDICAL INTERVENTION WAS NECESSARY. THE DONOR DID NOT HAVE ANY ADVERSE EVENTS FOR THE DRBC COLLECTION. THIS REPORT IS BEING FILED DUE TO OPERATOR ERROR THAT HAS THE POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM AUTOMATED BLOOD CELL SEPARATOR LKN CARDIANBCT 81000

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other