BEUDAMED
    FDA Adverse Event Other Summary report: N

    RBC (RBX) SET, SPECTRA

    MDR report key: 1890866 · Received October 28, 2010

    Report

    Report Number
    1722028-2010-00060
    Event Type
    Other
    Date Received
    October 28, 2010
    Date of Event
    May 26, 2010
    Report Date
    October 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PT HAD SICKLE CELL ANEMIA AND HIS TOTAL BLOOD VOLUME WAS RECORDED AS 5374 ML. HIS PRE-PROCEDURE HEMATOCRIT WAS 37%. THE OPERATOR DID NOT FOLLOW THE PROCEDURE FROM THE OPERATOR'S MANUAL. THEY FOLLOWED A CUSTOM PROTOCOL, DEVELOPED BY ONE OF THEIR PHYSICIANS. THIS PROTOCOL INVOLVED INITIATING AN RBC DEPLETION AND THEN CHANGING TO AN RBC EXCHANGE. THE FLUID BALANCE WAS SET AT 100%. THE CUSTOMER STATED THAT THEY DID NOT EXPERIENCE ANY ALARMS OR ISSUES DURING THE PROCEDURE. AFTER THE PROCEDURE WAS COMPLETED, THE MACHINE INDICATED THAT ABOUT 3500 ML SHOULD HAVE BEEN REMOVED FROM THE PT. THE COLLECT BAG APPEARED TO CONTAIN ONLY ABOUT 700-800 ML. THE PT'S HEMATOCRIT POST-PROCEDURE WAS 41.5%, HIGHER THAN THE 33% PREDICTED BY THE MACHINE. A PHYSICIAN WAS NOTIFIED. THE PHYSICIAN EVALUATED THE PT AND DETERMINED THAT THE PT WAS FINE. THE PT WAS ALLOWED TO LEAVE WITHOUT ANY MEDICAL INTERVENTION AND REPORTEDLY FELT WELL. THE "MACHINE CHECKOUT" DID NOT REVEAL ANY ISSUES WITH THE COBE SPECTRA EQUIPMENT. THE COBE SPECTRA DISPOSABLE WAS RECEIVED AND VISUALLY INSPECTED AND NONE WERE OBSERVED. ALSO, NO SIGNIFICANT "KINKS" WERE OBSERVED ON THE TUBING. THE SMALL INDENTATION THE CUSTOMER DESCRIBED AS A "KINK" WAS LOCATED ON THE RBC AND PLASMA LINES OF THE LOOP ASSEMBLY. THE INDENTATIONS OBSERVED AFTER THE KIT WAS RETURNED WERE NOT SEVERE ENOUGH TO FULLY OCCLUDE THE TUBING SET; HOWEVER, THESE INDENTATIONS COULD BE EVIDENCE THAT THE TUBING WAS PINCHED ENOUGH DURING THE PROCEDURE TO AFFECT THE FLUID PATHWAY. IF VOLUME IN COLLECT BAG WAS ACCURATE, HYPERVOLEMIA COULD RESULT. DOCTOR WAS AWARE OF THIS CONDITION.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVAL PROCESS THAT WERE PROMPTED BY AN FDA INSPECTION. THE FOLLOWING INCIDENT DESCRIPTION WAS PROVIDED TO CARIDIANBCT QUALITY ASSURANCE. AFTER A RED BLOOD CELL EXCHANGE (RBCX) PROCEDURE USING A COBE SPECTRA MACHINE AND A COBE SPECTRA DISPOSABLE, THE CUSTOMER REPORTED A DISCREPANCY BETWEEN THE RED CELL VOLUME COLLECTED AND THE VOLUME DISPLAYED BY THE COBE SPECTRA MACHINE. THE PT DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RBC (RBX) SET, SPECTRA SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 950000000 02S15270

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK