BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBCII BLOOD CONSERVATION RESERVOIR ONLY

    MDR report key: 2010236 · Received March 1, 2011

    Report

    Report Number
    2648666-2011-00059
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 2, 2011
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    CAC
    PMA / PMN Number
    K952224
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AT THE ACCOUNT. THE DEVICE HISTORY RECORD AND THE NON-CONFORMANCE DATABASE WERE REVIEWED FOR INCIDENTS RELATED TO THE ABOVE CONDITION WITHIN A 2 WEEKS PERIOD (+/-) FROM THE LOT MFG DATE. NO RELATED NON-CONFORMANCES OR DEVIATION REPORTS WERE FOUND THAT COULD CONTRIBUTE TO THE FAILURE ADDRESSED IN THIS COMPLAINT. NO PROCESS OR DESIGN CHANGES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COLLECTED BLOOD COAGULATED INSIDE THE RESERVOIR. NO ADVERSE CONSEQUENCES WERE REPORTED BY THE ACCOUNT. FURTHER INFO HAS BEEN REQUESTED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBCII BLOOD CONSERVATION RESERVOIR ONLY AUTOTRANSFUSION APPARATUS CAC STRYKER INSTRUMENTS PUERTO RICO 10162012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK