BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR W/O RESERVOIR

    MDR report key: 2840167 · Received November 13, 2012

    Report

    Report Number
    9681834-2012-00072
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 26, 2012
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT REC'D THE ACTUAL DEVICE FOR EVAL; HOWEVER THE INVESTIGATION HAS NOT BEEN COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING CARDIOPULMONARY BYPASS SURGERY, THE GAS TRANSFER OF THE OXYGENATOR DID NOT PERFORM AS EXPECTED. PT WAS A (B)(6) MALE WITH A BODY SURFACE AREA (B)(6). PUMP TIME OF 416 MINS (6 HRS AND 56 MINS). DURING THE FIRST 5 HRS OF CARDIOPULMONARY BYPASS (CPB) BOTH THE PAO2 AND PACO2 WERE WITHIN REASONABLE AND SAFE LEVELS DURING CPB. BLOOD GAS VALUES (PH: 7.34; PACO2: 44; PAO2: 285; AND SVO2 OF 75% ARE ALL WITHIN NORMAL LEVELS OF CPB WHICH INDICATES A FUNCTIONING OXYGENATOR. AT 6 HRS CHANGES STARTED TO OCCUR EVEN WITH INCREASING BLOOD FLOW, THE SVO2 DROPPED TO 61%. THIS INDICATES AN INCREASE IN THE OXYGEN CONSUMPTION TO THE PT. THE RESULTANT PAO2'S DROPPED TO THE 82 - 113 MMHG RANGE. A PAO2 OF 82 MMHG EQUATES TO AN OXYGEN SATURATION OF 96% AND EQUATES TO AN OXYGEN TRANSFER OF 300 ML/MIN. THIS INDICATES A HIGH AND ADEQUATE OXYGEN OF 300 ML/MIN. THIS INDICATES A HIGH AND ADEQUATE OXYGEN TRANSFER. EVEN THOUGH THE ACTIVATED CLOTTING TIME (ACT'S) WERE MAINTAINED IN A RANGE OF 452 TO 600 PLUS SECONDS, THERE IS A COMMENT IN THE PUMP RECORDS THAT CLOTS WERE NOTICED IN THE CARDIOTOMY/VENOUS RESERVOIR. AFTER CPB WAS TERMINATED, ANOTHER CIRCUIT WAS PRIMED AND PREPARED FOR CPB IN CASE CPB HAD TO BE RE-INSTITUTED THOUGHT THIS CIRCUIT WAS NOT USED. THE CASE WAS VERY COMPLEX AND VERY LONG WITH A PUMP RUN OF NEARLY 7 HRS. THE FX OXYGENATOR INFO FOR USE (IFU) STATES TO NOT EXCEED 6 HRS OF USE. THE LOWER PAO2S AND HIGHER GAS FLOWS WERE NOT EXPERIENCED UNTIL 6 HRS INTO CPB. CLOTS WERE OBSERVED IN THE CPB CIRCUIT LATE IN PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU), POST SURGERY, AS PER NORMAL ROUTINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX FX OXYGENATOR W/O RESERVOIR BLOOD-GAS OXYGENATOR DTZ TERUMO CORPORATION, ASHITAKA CX*FX25E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR