BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX OXYGENATOR W/ HS RESERVOIR

    MDR report key: 2153323 · Received June 30, 2011

    Report

    Report Number
    9681834-2011-00030
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 27, 2011
    Manufacturer
    TERUMO CORP, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION. TERUMO PLANS ON SUBMITTING A F/U 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 ON THE INITIATION OF CARDIOPULMONARY BYPASS SURGERY, BOTH THE ARTERIAL AND VENOUS BLOOD WERE DARK. THE FIO2 WAS INCREASED TO MAXIMUM CONCENTRATION OF 100% AND BLOOD WAS STILL DARK. CAME OFF OF BYPASS TO VENTILATE AND INCREASE OXYGENATION OF THE PT, CHECKED BLENDER CONNECTIONS AND RECIRCULATED BLOOD THROUGH THE RECIRCULATION LINE OF CIRCUIT AND BLOOD BECAME BRIGHTER, PO2 INCREASED TO 200MMHG. WENT BACK ON BYPASS AND BLOOD BECAME DARK AGAIN. THE OXYGENATOR WAS CHANGED OUT, THERE WAS 400CC OF BLOOD LOSS FROM CHANGE OUT, BACK ON BYPASS, PO2 WAS GREATER THAN 300MMHG, PT WEANED FROM CPB SUCCESSFULLY AND DISCHARGED TO ICU IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX FX OXYGENATOR W/ HS RESERVOIR BLOOD-GAS OXYGENATOR DTZ TERUMO CORP, ASHITAKA 1CX*FX15RW40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention