BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPIOX RX OXYGENATOR

    MDR report key: 3732804 · Received March 26, 2014

    Report

    Report Number
    1124841-2014-00031
    Event Type
    Death
    Date Received
    March 26, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 6, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORPORATION THAT IMMEDIATELY UPON INITIATION OF CARDIOPULMONARY BYPASS SURGERY THERE WAS A HIGH VOLUME IN THE RESERVOIR (4 LITERS) WITH THE VACUUM LEVEL ON (AT 40 MMHG). THE PERFUSIONIST LOWERED THE VACUUM LEVEL, HEMOCONCENTRATED THE BLOOD, AND CELL-SAVED TO BRING THE VOLUME OF THE RESERVOIR DOWN TO 3 LITERS. THE PERFUSIONIST OBSERVED FOAM POURING OUT OF THE VENOUS FILTER. LATER IN THE CASE, WITH FI02 AT 100%, THE P02 LEVEL WAS 170. WHEN THEY BEGAN VENTILATING THE PATIENT, THE P02 LEVEL RAISED TO 300. THE SURGERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2014, BUT THE PATIENT WAS PUT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) ON (B)(6) 2014. THE PATIENT EXPIRED ON (B)(6) 2014. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176298 CAPIOX RX OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. 3ZZ*RX25RE QN04

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death