BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE SPECTRA WHITE BLOOD CELL SET

    MDR report key: 1890079 · Received October 28, 2010

    Report

    Report Number
    1722028-2010-00057
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    September 1, 2008
    Report Date
    October 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INFORMATION GATHERED ABOUT THIS EVENT IS INSUFFICIENT TO DETERMINE A CAUSE OF THE AC REACTION. ALSO, SEVERAL ATTEMPTS WERE MADE TO GATHER INFORMATION FROM THE CUSTOMER SITE, BUT WE WERE UNABLE TO RECOVER THE LOT NUMBER INFORMATION. THE SETS FOR THESE PROCEDURES WERE NOT AVAILABLE FOR A SPECIFIC ROOT CAUSE ANALYSIS, CORRECTIVE AND PREVENTATIVE ACTIONS BY QUALITY ASSURANCE. THE SPECTRA MACHINE WAS SERVICED AND NO FUNCTIONALITY PROBLEMS WERE OBSERVED. UNFORTUNATELY, A DEFINITIVE ROOT CAUSE FOR THESE PATIENT AC REACTIONS REMAINS UNDETERMINED. NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FROM THIS CUSTOMER SITE AND FROM (B)(6) 2008 TO (B)(6) 2009 FOUR OTHER REPORTED PATIENT REACTIONS EVENTS HAVE OCCURRED. EACH OF THE FOUR WERE UNIQUE IN THAT THEY WERE DIFFERENT SITES, TIMES, DISPOSABLE LOT NUMBERS, EQUIPMENT SERIAL NUMBERS, AND PATIENT CONDITIONS. THIS INDICATES THAT THERE IS NO IMMERGING TREND DIRECTLY CORRELATED TO A DISPOSABLE LOT NUMBER OR MACHINE. A SINGLE IDEAL VALUE OF AC TO BE DELIVERED SAFELY CANNOT BE ESTABLISHED FOR ALL DONORS OR PATIENTS BECAUSE EACH INDIVIDUAL IS DIFFERENT AND IN VARIOUS STATES OF HEALTH. THE COBE SPECTRA APHERESIS SYSTEM ESSENTIAL GUIDE RECOMMENDS THAT THE CONDITION OF THE DONOR OR PATIENT BE ASSESSED FREQUENTLY THROUGHOUT THE APHERESIS PROCEDURE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVALUATION PROCESS THAT WERE PROMPTED BY AN FDA INSPECTION. DUE TO THE POTENTIAL FOR INJURY BY MEANS OF A REACTIONS WITH THE ANTICOAGULANT (AC) USED DURING THE PROCEDURE AND A SET OF INCOMPLETE INFORMATION, THIS COMPLAINT WILL BE CONSIDERED A HIGH PRIORITY EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA WHITE BLOOD CELL SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention