BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CBCII BLOOD CONSERVATION KIT W

    MDR report key: 672844 · Received February 6, 2006

    Report

    Report Number
    2648666-2006-00008
    Event Type
    Injury
    Date Received
    February 6, 2006
    Date of Event
    December 20, 2005
    Report Date
    December 21, 2005
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT WOULD NOT REINFUSE, THEREFORE, PATIENT HAD TO RECEIVE A BLOOD TRANFUSION OF THEIR OWN, PRE-DONATED BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBCII BLOOD CONSERVATION KIT W APPARATUS, AUTO TRANSFUSION CAC STRYKER INSTRUMENTS PUERTO RICO * 05258012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention