BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX SX OXYGENATOR W/HARDSHELL RESERVOIR

    MDR report key: 1961366 · Received January 6, 2011

    Report

    Report Number
    1124841-2011-00006
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 24, 2010
    Report Date
    December 16, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K993772
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETED AND MORE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING CARDIOPULMONARY BYPASS SURGERY, THE HLM TUBING CIRCUIT FELL OFF THE SX OXYGENATOR VENOUS OUTLET PORT. THE PRODUCT WAS NOT CHANGED OUT. THERE WAS 400-500ML OF BLOOD LOSS. THERE WAS NO HARM TO THE PT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX SX OXYGENATOR W/HARDSHELL RESERVOIR BLOOD-GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. NA LN09

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening