BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CBC II-(1/8" KIT) PKG/6 WORLD

    MDR report key: 2212939 · Received August 4, 2011

    Report

    Report Number
    2648666-2011-00184
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 8, 2011
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    CAC
    PMA / PMN Number
    K952224
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT REPORTED THAT THE VACUUM INDICATOR WAS NOT INVERTED ON THE DEVICE. IF VACUUM INDICATOR IS NOT COMPLETELY INVERTED, AN AIR LEAK IS INSIDE THE SYSTEM COULD BE CAUSING THE NO VACUUM CONDITION. THE DEVICE HISTORY RECORD, THE NON-CONFORMANCE REPORTS DATABASE AND DEVIATION REPORTS WERE REVIEWED WITHIN A 2 WEEKS PERIOD (+/-) FROM THE LOT MANUFACTURING 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. THE DEVICE WAS DISCARDED AT THE ACCOUNT AND IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A TKA, THE DEVICE DID NOT CREATE A VACUUM. THE INTENDED RE-INFUSION OF COLLECTED BLOOD WAS NOT ABLE TO BE PERFORMED. THE PT RECEIVED A BLOOD TRANSFUSION FROM PRE-DONATED BLOOD. IT WAS FURTHER REPORTED THAT THE PT SUSTAINED A HEMATOMA THAT REQUIRED A SURGICAL PROCEDURE TO CORRECT. NO FURTHER INFORMATION HAS BEEN RECEIVED REGARDING THE TYPE OF PROCEDURE THAT WAS PERFORMED OR THE STATUS OF THE PT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBC II-(1/8" KIT) PKG/6 WORLD CAC STRYKER INSTRUMENTS PUERTO RICO 11003012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention