BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBC II-(3/16" KIT) PKG/6 WORLD

    MDR report key: 2090241 · Received April 19, 2011

    Report

    Report Number
    2648666-2011-00107
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 22, 2011
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    CAC
    PMA / PMN Number
    K952224
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CBCII PRODUCT FAMILY IS USED AS A CLOSED BLOOD RECOVERY SYS USED POST-OPERATIVELY TO COLLECT, FILTER, AND ALLOW FOR REINFUSION OF AUTOLOGOUS BLOOD. THE UNIT WAS DISCARDED BY THE ACCOUNT AND THE LOT NUMBER WAS NOT PROVIDED TO THE MANUFACTURER. THEREFORE, THE ROOT CAUSE FOR THE CLAIMED CONDITION (COAGULATED BLOOD) COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLOOD CLOTTED AT THE FILTER IN THE RESERVOIR, THEN IT COULD NOT DELIVER THE BLOOD TO THE BLOOD BAG. THE CLOTTED BLOOD WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBC II-(3/16" KIT) PKG/6 WORLD CAC STRYKER INSTRUMENTS PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK