BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAPIOX RX OXYGENATOR W/HS RESERVOIR

    MDR report key: 2170107 · Received June 20, 2011

    Report

    Report Number
    1124841-2011-00267
    Event Type
    Other
    Date Received
    June 20, 2011
    Date of Event
    May 28, 2011
    Report Date
    May 31, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K062381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID NOT RECEIVE THE ACTUAL DEVICE FOR EVALUATION. TERUMO DID CONFIRM THAT THE NEW STYLE GAS OUTLET PORT WAS DESIGNED TO ALLOW PERFUSIONIST THE OPTION OF ATTACHING A LINE TO PORT. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING SET-UP, THEY NOTED THE RECENT CHANGE TO THE GAS OUTLET PORT ON THE OXYGENATOR. THE PRODUCT WAS NOT CHANGED OUT. THERE WAS NO PT INVOLVEMENT AS THIS OCCURRED DURING SET-UP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX RX OXYGENATOR W/HS RESERVOIR BLOOD-GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. NA NA10

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK