BEUDAMED
    FDA Adverse Event Death Summary report: N

    FX OXY W/O RESERVOIR

    MDR report key: 3322049 · Received August 27, 2013

    Report

    Report Number
    9681834-2013-00108
    Event Type
    Death
    Date Received
    August 27, 2013
    Date of Event
    August 7, 2013
    Report Date
    August 8, 2013
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, AN 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

    IT WAS REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS, BY THE CERTIFIED CLINICAL PERFUSIONIST (CCP) ON THE CASE, THAT THE WRONG FX OXYGENATOR (1CX FX25W) WAS OPENED IN THE OPERATING ROOM TWICE DURING AN EMERGENT CASE BECAUSE OF AN INCORRECT SHIPMENT TO THE FACILITY. THE ACTUAL SURGICAL PROCEDURE HAD BEEN COMPLETED, AND THE CARDIOPULMONARY BYPASS (CPB) CIRCUIT HAS BEEN DISCARDED. PRIOR TO THE PT BEING TRANSFERRED TO THE INTENSIVE CARE UNIT, THE PT BECAME HEMODYNAMICALLY UNSTABLE WITH SIGNS OF HEART FAILURE. THE CARDIOVASCULAR SURGEON ELECTED TO RETURN THE PT TO CPB IN ORDER TO SUPPORT THE FAILING CIRCULATION. AS THE CPB CIRCUIT COMPONENTS WERE BEING OPENED, THE OPENED WAS ALSO A 1CX FX25W UNIT. A THIRD UNIT WAS OPENED, AND IT WAS VERIFIED TO BE THCCP OBSERVED THAT THE OXYGENATOR WAS NOT THE ROUTINE 1CX FX25W UNIT. A SECOND OXYGENATOR WAS E ROUTINE (1CX FX25E) DEVICE. ALL THREE UNITS WERE STORED IN THE OPERATING ROOM; THEREFORE, THERE WAS NO DELAY INTO THE START OF CPB. THE PT EXPIRED FROM CIRCULATORY COLLAPSE PRIOR TO REINSTATING THE CPB PROCEDURE. THE CCP STATED THAT THE INCORRECT UNITS HAD NO IMPACT ON THE OUTCOME OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418017 FX OXY W/O RESERVOIR BLOOD-GAS OXYGENATOR DTZ TERUMO CORPORATION, ASHITAKA NA 130307

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death