BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBCII BLOOD CONSERVATION KIT W/1/8 INCH ROUND PVC

    MDR report key: 2090692 · Received April 19, 2011

    Report

    Report Number
    2648666-2011-00104
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 21, 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 DEVICE WAS NOT AVAILABLE FOR EVAL. THE DEVICE HISTORY RECORD, THE NON-CONFORMANCE REPORTS DATABASE AND DEVIATION REPORTS WERE REVIEWED FOR INCIDENTS RELATED TO THE ABOVE CONDITION WITHIN A 2 WEEK 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 OF DESIGN CHANGES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DID NOT PULL ENOUGH OF A VACUUM TO FUNCTION PROPERLY. A SMALL AMOUNT OF BLOOD WAS COLLECTED WITH THIS DEVICE. NONE OF THE COLLECTED BLOOD WAS ABLE TO BE RE-INFUSED. THE PT DID NOT REQUIRE A BLOOD TRANSFUSION FROM EITHER A BLOOD BANK OR PRE-DONATED BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBCII BLOOD CONSERVATION KIT W/1/8 INCH ROUND PVC CAC STRYKER INSTRUMENTS PUERTO RICO 10337012

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR