BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

    MDR report key: 1940951 · Received December 17, 2010

    Report

    Report Number
    1722028-2010-00078
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    December 29, 2008
    Report Date
    December 17, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK030083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER NOTICED THE AIR IN THE RETURN LINE LESS THAN A MINUTE AFTER BLOOD PRIME. THIS APPARENTLY WAS RIGHT AFTER AN ADJUSTMENT WAS MADE TO THE VENIPUNCTURE, IN WHICH THE PAUSE BUTTON WAS NOT USED. THE CUSTOMER ENDED THE RUN IMMEDIATELY AND IT WAS REPORTED THERE WAS NO AIR RETURNED TO THE DONOR. THE DONOR HAD NO REACTION AT ALL AND WAS FINE UPON LEAVING THE SITE. THE TUBING SET WAS NOT AVAILABLE FOR RETURN. IT SEEMS AS THOUGH AIR WAS PROBABLY BROUGHT INTO THE SYSTEM DURING THE ADJUSTMENT. THIS IS BECAUSE THE SYSTEM WASN'T PAUSED AND BECAUSE THE CUSTOMER REPORTED AN INCH OF FLUID COVERING THE LOWER LEVEL SENSOR IN THE RETURN RESERVOIR. OF COURSE, WE DON'T KNOW FOR SURE, SO I WILL PLACE A SERVICE CALL AND WE WILL ANALYZE THE RDF. THE INFORMATION FOR THE RDFS ARE AS FOLLOWS: SN (B)(4). SERVICE CALL WAS PLACED FOR THIS SYSTEM AND THE TRIMA WAS TAKEN OUT OF SERVICE. THROUGH LOOKING AT THE RDF FILES, WE WERE ABLE TO DETERMINE THAT NOTHING SEEMED OUT OF THE ORDINARY WITH THE RUN. THE PROCEDURE LASTED ABOUT A MINUTE AND 30 SECONDS AND WAS IN A DRAW THE WHOLE TIME. THERE WERE SOME DRAW PRESSURE LOW ALARMS, BUT NO AIR DETECTED OR LEVEL SENSOR ERRORS. CONCLUSION: IT APPEARS THAT THE AIR IN THE SYSTEM WAS CAUSED BY THEY OPERATOR ADJUSTING THE VENIPUNCTURE NEEDLE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVALUATION PROCESS. WE HAVE CHANGED OUR PROCESS TO BETTER ALIGN WITH CURRENT AGENCY POLICY. THE CUSTOMER NOTICED THE AIR IN THE RETURN LINE LESS THAN A MINUTE AFTER BLOOD PRIME. THIS APPARENTLY WAS RIGHT AFTER AN ADJUSTMENT WAS MADE TO THE VENIPUNCTURE, IN WHICH THE PAUSE BUTTON WAS NOT USED. THE CUSTOMER ENDED THE RUN IMMEDIATELY AND IT WAS REPORTED THERE WAS NO AIR RETURNED TO THE DONOR. THE DONOR HAD NO REACTION AT ALL AND WAS FINE UPON LEAVING THE SITE. THE COMPLAINANT WAS UNABLE TO PROVIDE A PT IDENTIFIER. THIS REPORT IS BEING FILED DUE TO THE POTENTIAL FOR INJURY FROM AIR BEING RETURNED TO THE DONOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 81000 11P1111

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention