BEUDAMED
    FDA Adverse Event Summary report: N

    CAPIOX SX OXYGENATOR W/ HARDSHELL RESERVOIR

    MDR report key: 1930213 · Received December 8, 2010

    Report

    Report Number
    1124841-2010-00222
    Date Received
    December 8, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 18, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K993772
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVAL; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. TERUMO WILL BE 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 SYSTEMS THAT DURING CARDIOPULMONARY BYPASS, WITH A 90% FIO2 (BLENDER), PERFUSIONIST DECIDED TO TURN FIO2 INTO 100%. ANOTHER GASOMETRY WAS REQUIRED AND PO2 BECAME LOWER (66 MMHG). PERFUSIONIST THOUGHT IT MIGHT BE THE GASOMETER EQUIPMENT HAD A FAILURE, AND THAT MAYBE THE BLENDER WAS NOT WORKING. THE PERFUSIONIST ASKED FOR A GASOMETRY TO BLOOD LABORATORY AND AN OXYGEN TANK AND THIS GASOMETRY SHOWED A WORSE CASE SCENARIO, WITH A PO2 OF 31 MMHG. THE PERFUSIONIST DECIDED TO GO BACK ON BLENDER. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PT INJURY.

    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. 3CXSX18R ME05

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK