BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

    MDR report key: 2062768 · Received April 8, 2011

    Report

    Report Number
    1722028-2011-00037
    Event Type
    Other
    Date Received
    April 8, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 4, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK030083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVAL: THE DEVICE RUN DATA FILE (RDF) WAS ANALYZED AND SHOWS THAT THE OPERATOR CHANGED THE DONOR'S WEIGHT SEVEN TIMES UNTIL ACHIEVING A TBV THAT WOULD ALLOW THE DOUBLE RED CELL PROCEDURE. THE FINAL TBV IN THE RDF WAS 4563 MLS. INVESTIGATION: THE CUSTOMER HAS CONFIGURED THEIR EQUIPMENT TO ALLOW DOUBLE RED CELL COLLECTIONS AT 4.5 L. THE RDF ANALYSIS REVEALS THAT THE OPERATOR CHANGED THE DONOR'S WEIGHT INFO SEVEN TIMES UNTIL THEY WERE AT A TBV HIGH ENOUGH TO COLLECT A DOUBLE RED CELL PRODUCT. THIS IS A CONFIRMED OPERATOR ERROR. A REVIEW OF THE DHR FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MFR THAT WERE RELEVANT TO THIS ISSUE. THE DEVICE OPERATED AS INTENDED. ROOT CAUSE: OPERATOR ERROR. CORRECTIVE/PREVENTIVE ACTION: THE CUSTOMER RECEIVED THE RDF ANALYSIS ALONG WITH SOME RE-TRAINING ABOUT RUNNING PROCEDURES USING THE CORRECT DONOR INFO. 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

    A CUSTOMER CALLED TO HAVE THE DEVICE RUN DATA FILE INVESTIGATED AS THEY WERE CONCERNED THAT THEY WERE ABLE TO RUN A DOUBLE RED BLOOD CELL COLLECTION PROCEDURE ON A DONOR WITH A TBV OF 4263 ML. THEIR DEVICE IS CONFIGURED TO NOT ALLOW A DOUBLE RED BLOOD CELL COLLECTION PROCEDURE WITH A TBV LESS THAN 4500 ML. THE PROCEDURE WAS COMPLETED WITH NO ISSUES. THERE WAS NO MEDICAL INTERVENTION PERFORMED IN THIS INCIDENT. THE INCIDENT OCCURRED ON (B)(6) 2011, BUT WAS NOT DISCOVERED BY THE SITE UNTIL (B)(6) 2011. A PT IDENTIFIER WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other