BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL AUTOMATED BLOOD COLLECTION SET

    MDR report key: 1952123 · Received December 29, 2010

    Report

    Report Number
    1722028-2010-00144
    Event Type
    Other
    Date Received
    December 29, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    GKT
    PMA / PMN Number
    BK030083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DISPOSABLE SET WAS UNAVAILABLE FOR RETURN AND INVESTIGATION. THE DISPOSABLE SET HAD BEEN THROWN AWAY, SO IT COULD NOT BE EVALUATED. THE CUSTOMER ASKED THE CLINICAL SUPPORT SPECIALIST IF THERE WAS THE POTENTIAL FOR ANY AIR TO BE RETURNED TO THE DONOR. TO ANSWER THIS QUESTION, THE RUN DATA FILE FOR THIS DONATION WAS ANALYZED. THERE WERE THIRTY-TWO "ACCESS PRESSURE SENSOR (APS) SLOWING" ALERTS AND SEVEN "ACCESS PRESSURE TOO LOW" ALARMS. THE SIGNALS IN THE RUN DATA FILE SHOWED THAT AT APPROX 48 MINUTES INTO THE PROCEDURE, THERE WAS A CHANGE IN THE ACCESS PRESSURE PROFILE FOLLOWED BY A "CENTRIFUGE PRESSURE TOO HIGH" ALARM WHICH STOPPED THE SYSTEM. THE OPERATOR THEN ENDED THE PROCEDURE AND THE DONOR WAS DISCONNECTED WITHOUT RINSEBACK. THE CHANGE IN THE ACCESS PRESSURE PROFILE IS MOST LIKELY DUE TO THE ACCESS NEEDLE BECOMING DISLODGED. THIS ALLOWED AIR TO BE DRAWN INTO THE SET THROUGH THE INLET LINE. THE AIR IN THE INLET WAS THEN SEEN BY THE CENTRIFUGE PRESSURE SENSOR AND TRIGGERED THE "CENTRIFUGE PRESSURE TOO HIGH" ALARM, WHICH THEN STOPPED THE CENTRIFUGE. NO AIR WAS RETURNED TO THE DONOR. CONCLUSION: BASED ON THE CUSTOMER DESCRIPTION OF THE INCIDENT AND THE ANALYSIS OF THE RUN DATA FILE, THE ACCESS NEEDLE BECAME DISLODGED FROM THE DONOR'S VEIN. THIS ACCESS ISSUE WAS LIKELY CAUSED BY PHLEBOTOMY TECHNIQUE BASED ON THE ACCESS PRESSURE ALARMS SEEN IN THE RUN DATA FILE. THE NEEDLE BACKING OUT OF THE DONOR'S ARM THEN ALLOWED AIR TO ENTER THE DISPOSABLE SET THROUGH THE INLET LINE AND TRIGGERED THE CENTRIFUGE PRESSURE ALARM.

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINANT, TOWARDS THE END OF THE PROCEDURE, THE DONOR COMPLAINED OF SOME "CHEST TINGLING." THE OPERATOR STOPPED THE PROCEDURE AND NOTICED BLOOD DRIPPING DOWN THE DONOR'S ARM. THE OPERATOR REPORTED THAT THERE WAS AIR ALL THE WAY UP THE RETURN LINE TO THE RESERVOIR AND WAS CONCERNED THAT AIR COULD HAVE BEEN RETURNED TO THE DONOR. THE OPERATOR THEN TOLD THE DONOR THAT HE MAY HAVE RECEIVED SOME AIR AND SENT HIM TO THE HOSPITAL. THIS REPORT IS BEING FILED DUE TO MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL AUTOMATED BLOOD COLLECTION SET SEPARATOR, AUTOMATED, PLATELET, AND PL GKT CARIDIANBCT 05S1128

    Patients

    Seq Age Sex Outcome Treatment
    1 Other