BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 2092594 · Received May 9, 2011

    Report

    Report Number
    1212122-2011-00098
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID RECEIVE THE ACTUAL DEVICE AND FURTHER INVESTIGATION IS NECESSARY. TERUMO PLANS ON SUBMITTING A F/U REPORT WHEN MORE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THE TUBING DISCONNECTED FROM THE VENOUS RESERVOIR OUTLET. THE PRODUCT WAS NOT CHANGED OUT, THERE WAS 1000 ML BLOOD LOSS, AND SURGERY WAS COMPLETED SUCCESSFULLY. THE EVENT DID CAUSE A 2 MINUTE DELAY IN SURGICAL PROCEDURE. TWO UNITS OF RED BLOOD RED CELL TRANSFUSION WERE REQUIRED TO PREVENT INJURY. THERE WAS NO VISIBLE HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOVASCULAR PROCEDURE KIT CONVENIENCE TUBING PACK OEZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ND07

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention