BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

    MDR report key: 1942905 · Received December 21, 2010

    Report

    Report Number
    1722028-2010-00141
    Event Type
    Other
    Date Received
    December 21, 2010
    Date of Event
    May 11, 2009
    Report Date
    December 21, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK030083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIN (B)(4). RUN DATA FILES WERE RETRIEVED FOR ANALYSIS. THE ALARM "RETURN PRESSURE TOO HIGH" OCCURS IF THERE IS A PROBLEM WITH THE VEIN ACCESS SITE. WHEN THE ALARM OCCURS, THE OPERATOR IS INSTRUCTED TO: "CHECK THE DONOR'S ACCESS SITE. VERIFY THAT THE NEEDLE IS PROPERLY SEATED. CHECK FOR POSSIBLE INFILTRATION. IF NECESSARY, REPOSITION THE NEEDLE TO ENSURE PROPER PLACEMENT IN THE DONOR'S VEIN. "THE SYSTEM OPERATED AS INTENDED AND THE OPERATOR TOOK APPROPRIATE ACTION TO END THE RUN AND REMOVE THE DONOR DUE TO PROBLEMS WITH THE VEIN ACCESS. THE AVAILABLE INFO INDICATES THAT THE INFILTRATION WAS MINOR. THE MACHINE WAS ALARMING APPROPRIATELY WITH A RETURN PRESSURE ALERT DURING THE RUN, REQUIRING OPERATOR ACTION. OPERATOR'S MANUAL 777820-995 (2002/6) PG. X, ITEM 30: "THE DRAW/RETURN PRESSURE SENSOR IS NOT INTENDED TO DETECT ALL INFILTRATIONS OF THE VEIN. RIGOROUS ATTENTION SHOULD BE PAID TO PROPER VENIPUNCTURE SITE SELECTION AND DECONTAMINATION." ROOT CAUSE: INFILTRATION LIKELY RELATED TO POOR VEIN PUNCTURE AND/OR NOT MONITORING PUNCTURE SITE ADEQUATELY.

    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 REPORTED A RETURN PRESSURE TOO HIGH ALARM DURING A PROCEDURE ON TRIMA SN (B)(4). DURING THE CALL, IT BECAME KNOWN THAT THE DONOR EXPERIENCED AN INFILTRATION AT THE VEIN ACCESS SITE. THREE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN A PT IDENTIFIER AND WHETHER THERE WAS MEDICAL INTERVENTION. THIS REPORT IS BEING FILED DUE TO THE POTENTIAL FOR MEDICAL INTERVENTION.

    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 917000000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other