BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE SPECTRA APHERESIS SYSTEM TPE SET

    MDR report key: 1974720 · Received December 29, 2010

    Report

    Report Number
    1722028-2010-00111
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    February 7, 2009
    Report Date
    December 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER WAS SEEING BUBBLES IN THE RETURN LINE AFTER CONNECTING THE BLOOD WARMER. THE CARIDIANBCT CUSTOMER SUPPORT SPECIALIST ASKED THE CUSTOMER TO MAKE SURE THE BLOOD WARMER WAS PRIMED AND TO CHECK THE CONNECTION THAT HE NEEDED TO MAKE MANUALLY. THE CUSTOMER PROCEEDED TO UNLOAD THE DISPOSABLE SET AND TO REPLACE IT WITH A NEW ONE FROM THE SAME LOT. THE SECOND SET PERFORMED AS INTENDED. THE ORIGINAL DISPOSABLE SET WAS UNAVAILABLE FOR RETURN AND INVESTIGATION. THE CASCADE OF EVENTS REQUIRED TO ALLOW AIR TO ENTER A LINE THAT WOULD NORMALLY BE UNDER POSITIVE PRESSURE IS THE FOLLOWING: USE OF A BLOOD WARMER CONNECTED TO THE RETURN LINE LUER. BLOOD WARMER TUBING ELEVATED TO THE TOP OF THE IV POLE DURING RUN. PRESENCE OF A LEAK AT THE CONNECTION OF THE SPECTRA TUBING SET AND BLOOD WARMER TUBING. PT RETURN VENOUS PRESSURE LESS THAN THE HEAD HEIGHT PRESSURE OF THE DEFECT ABOVE THE VENOUS RETURN SITE. ANALYSIS AND TESTING PROVED THIS SCENARIO IS REPEATABLE WHEN ALL OF THESE CONDITIONS ARE EXACTLY MET. CONCLUSION: CONTEXT OF USAGE CONTRIBUTED TO THE EVENT.

    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 REPORTED HE WAS SEEING SOME BUBBLES IN THE RETURN LINE AFTER CONNECTING THE BLOOD WARMER. THIS REPORT IS BEING FILED DUE TO THE POTENTIAL OF AIR TO THE PT. THE CUSTOMER DECLINED TO PROVIDE A PT IDENTIFIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA APHERESIS SYSTEM TPE SET SEPARATOR, AUTOMATED, BLOOD CELL AND P1 LKN CARIDIANBCT 11R15242

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK