BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FX OXY W/HR & ART FILTER RESERVOIR

    MDR report key: 4679772 · Received April 8, 2015

    Report

    Report Number
    9681834-2015-00061
    Event Type
    Injury
    Date Received
    April 8, 2015
    Date of Event
    March 23, 2015
    Report Date
    March 25, 2015
    Manufacturer
    TERUMO CORP, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K112229
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. FOR THIS REASON, TERUMO REFERENCES EVALUATION CONCLUSION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP THAT UPON INITIATING CARDIOPULMONARY BYPASS, THEY EXPERIENCED FLOW ISSUES WHILE USING THE FX15 OXYGENATOR. PRIMING OF THE CIRCUIT HAD NO ISSUES. THE PATIENT HAD A BSA OF 1.98 AND WAS EMERGENTLY PLACED ON CPB AFTER BECOMING HEMODYNAMICALLY UNSTABLE. AS CPB WAS INITIATED, THE TARGET BLOOD FLOW RATE WAS 4.8 L/MIN, WHILE THE MAXIMUM FLOW RATE PRODUCED WAS ONLY 3.6 L/MIN, EVEN THOUGH THE RPM HAD BEEN GRADUALLY RAISED TO 3600 RPM. DURING THE NEXT 5 MINUTES, THE FLOW RATE HAD DECREASED TO ABOUT 2.5 - 2.75 L/MIN. THE CIRCUIT LINE PRESSURE WAS MEASURED JUST AFTER THE OXYGENATOR AT NORMAL VALUES OF 180-200MMHG. VARIOUS ADJUSTMENTS WERE MADE WITH NO AFFECT SO THE UNIT WS CHANGED OUT RESULTING IN THE PATIENT LOSING 200-300CC OF BLOOD THAT REMAINED IN THE ORIGINAL CIRCUIT. THE PROCEDURE WAS DELAYED APPROXIMATELY 40 MINS DUE TO THE ISSUE AND PRODUCT CHANGEOUT. THERE WERE NO ISSUES THROUGHOUT THE REMAINDER OF THE PROCESS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT HARM WAS OBSERVED. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232644 FX OXY W/HR & ART FILTER RESERVOIR BLOOD GAS OXYGENATOR DTZ TERUMO CORP, ASHITAKA 1CX*FX15E 140715

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other