BEUDAMED
    FDA Adverse Event Death Summary report: N

    BLOOD GAS OXYGENATOR

    MDR report key: 9577200 · Received January 10, 2020

    Report

    Report Number
    1124841-2020-00009
    Event Type
    Death
    Date Received
    January 10, 2020
    Report Date
    April 22, 2020
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS ¿ AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS IN THE INITIAL REPORT SUBMITTED TO THE FDA ON JANUARY 10, 2020. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: G4 (DATE RECEIVED BY MANUFACTURER), G7 (INDICATION THAT THIS IS A FOLLOW-UP REPORT), H2 (FOLLOW-UP DUE TO ADDITIONAL INFORMATION), H6 (IDENTIFICATION OF EVALUATION CODES 4114, 3221, 4315), METHOD CODE: 4114 - DEVICE NOT RETURNED, RESULTS CODE: 3221 - NO FINDINGS AVAILABLE, CONCLUSIONS CODE: 4315 - CAUSE NOT ESTABLISHED. THE AFFECTED SAMPLE WAS NOT RETURNED, SO A THOROUGH INVESTIGATION COULD NOT BE PERFORMED AND A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. SINCE THE PRODUCT CODE WAS UNKNOWN, DEVICE HISTORY RECORD AND INCOMING INSPECTION RECORD COULD NOT BE REVIEWED. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE 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 WHEN MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR, THAT DURING CARDIOPULMONARY BYPASS (CPB) A PLASMA LEAK WAS OBSERVED. PER USER FACILITY, THE PATIENT WAS IN FOR DAVINCI ROBOTIC REMOVAL OF LEFT ATRIAL MYXOMA AND THE CLOSURE OF A PATENT FORAMEN OVALE (PFO) WITH COMPLICATIONS THAT RESULTED IN OVER 9 HOURS ON CARDIOPULMONARY BYPASS SUPPORT. PER USER FACILITY THERE WAS NO PERFORMANCE DEGRADATION IN THE FIRST UNIT. THE UNIT WAS CHANGED OUT AFTER 6.5 HOURS, HOWEVER BECAUSE OF PATIENT'S INSTABILITY, CPB WAS REINITIATED AND THEY WERE ON BYPASS FOR ANOTHER 3 HOURS. THE SECOND UNIT DEVELOPED A PLASMA LEAK AGAIN WITH NO DOWNTURN IN GAS EXCHANGE PERFORMANCE. THE PATIENT WAS WEANED FROM BYPASS ON THE SECOND OXYGENATOR WITH AN ATTEMPT OF EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE PATIENT RECEIVED LOTS OF BLOOD AND CRYSTALLOID HOWEVER DID NOT SURVIVE THE PROCEDURE. IN ADDITION ACCORDING TO USER FACILITY GIVEN THE PATIENT¿S HISTORY, COPIOUS AMOUNTS OF TRANSFUSION, NO PERFORMANCE DEGRADATION AND THE LENGTH OF TIME ON CPB. THEY WERE NOT SURPRISED THAT SOME PLASMA LEAKAGE WOULD OCCUR. IT IS UNKNOWN IT THERE WAS DELAY. IT IS UNKNOWN IF THERE WAS BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41104 BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION UNKNOWN XA19

    Patients

    Seq Age Sex Outcome Treatment
    1 Death