BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

    MDR report key: 1940931 · Received December 17, 2010

    Report

    Report Number
    1722028-2010-00076
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    April 15, 2009
    Report Date
    December 17, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK0300083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAFETY REVIEW: HEALTH HAZARD ANALYSIS #(B)(4) DISCUSSES THE HAZARDS ASSOCIATED WITH ATTACHING A DONOR BEFORE LOADING THE CASSETTE. LIKELIHOOD FOR THIS EVENT WAS RATED "REMOTE". THERE WAS NO DONOR REACTION IN THIS CASE AND NO AIR WAS DELIVERED BECAUSE THE CASSETTE WAS NOT LOADED (ACCORDING TO THE CUSTOMER). FIELD DIAGNOSIS/CORRECTION: THERE WAS NO ALLEGED MACHINE MALFUNCTION. INVESTIGATION: TREND ANALYSIS INDICATES 3 OTHER INCIDENTS SIMILAR TO THIS. IN THIS CASE, THE OPERATOR REALIZED THE ERROR IMMEDIATELY, PRIOR TO LOADING THE CASSETTE. THE DONOR DID NOT RECEIVE AN AIR EMBOLISM. CONCLUSION: OPERATOR ERROR. CORRECTIVE/PREVENTIVE ACTION: OPERATOR ERROR ISSUES ARE REPORTED ON A QUARTERLY BASIS TO QUALITY, SALES AND CLINICAL SUPPORT FOR TARGETED TRAINING WHERE REQUIRED. AIR TO DONOR FAILURES ARE MITIGATED THROUGH PRODUCT LABELING.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVAL PROCESS. WE HAVE CHANGED OUR PROCESS TO BETTER ALIGN WITH CURRENT AGENCY POLICY. CUSTOMER CALLED TO REPORT A POTENTIAL ISSUE WITH A DONOR BEING CONNECTED BEFORE THEY WERE SUPPOSED TO ON THE MACHINE. WANTED TO KNOW ABOUT POTENTIAL SAFETY ISSUES AND MACHINE ALARMS THAT WOULD OCCUR. THE COMPLAINANT WAS UNABLE TO PROVIDE A PT IDENTIFIER. THIS REPORT IS BEING FILED DUE TO THE POTENTIAL FOR AIR BEING RETURNED TO THE DONOR DUE TO OPERATOR ERROR.

    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 18 YR Other