BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 3720547 · Received April 2, 2014

    Report

    Report Number
    9681834-2014-00066
    Event Type
    Death
    Date Received
    April 2, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 10, 2014
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVALUATION; HOWEVER, THE INVESTIGATION HAS YET TO BE COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. A RETENTION SAMPLE WAS VISUALLY INSPECTED AND NO ANOMALIES WERE FOUND WHICH WOULD RELATE TO THE REPORTED GAS TRANSFER PERFORMANCE ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO INDICATION OF PRODUCTION RELATED ANOMALIES, AND A REVIEW OF THE COMPLAINT FILE FOUND NO OTHER REPORT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE WAS RETURNED TO THE MANUFACTURING FACILITY FOR INSPECTION AND TESTING. VISUAL INSPECTION CONFIRMED THERE WERE NO ANOMALIES OR BREAKS IN THE APPEARANCE OF THE DEVICE. THE OXYGENATOR MODULE WAS FILLED WITH A PRIMING SOLUTION AND THE GAS TRANSFER SYSTEM WAS PERFORMANCE TESTED IN ACCORDANCE WITH THE FACTORY'S SHIPPING INSPECTION PROTOCOL. NO ANOMALIES WERE REVEALED CONFIRMING THE DEVICE MET PRODUCT SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORD INDICATED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN REPORTED PREVIOUSLY. BASED UPON THE AVAILABLE INFORMATION, THE CAUSE FOR THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED. THERE ARE MANY COMPLEX CLINICAL VARIABLES THAT MAY HAVE AFFECTED THE REPORTEDLY OBSERVED CONDITIONS DURING THE PROCEDURE. HOWEVER, THERE IS NO INDICATION THAT THE REPORTED EVENT WAS RELATED TO A PRODUCT MALFUNCTION OR DEFECT. THE POTENTIAL FOR SUCH AN EVENT IS ADDRESSED IN THE WARNINGS / PRECAUTIONS SECTION OF THE INSTRUCTIONS-FOR-USE BY STATEMENTS SUCH AS: "A PHENOMENON CALLED WET LUNG MAY OCCUR WHEN WATER CONDENSATION OCCURS INSIDE FIBERS OF MICROPOROUS MEMBRANE OXYGENATORS WITH BLOOD FLOWING EXTERIOR TO THE FIBERS. THIS MAY OCCUR WHEN OXYGENATORS ARE USED FOR A LONGER PERIOD OF TIME. IF WATER CONDENSATION AND/OR A DECREASE IN PAO2 AND/OR AN INCREASE IN PACO2 IS NOTED DURING EXTENDED OXYGENATOR USE, BRIEFLY INCREASING THE GAS FLOW RATE MAY IMPROVE THE PERFORMANCE. INCREASE GAS FLOW RATE TO 20L/MIN FOR 10 SECONDS. DO NOT REPEAT THIS FLUSHING TECHNIQUE, EVEN IF OXYGENATOR PERFORMANCE IS NOT IMPROVED;" AND "UPON PATIENT REWARMING, ADJUST O2 CONCENTRATION, GAS FLOW RATE AND BLOOD FLOW RATE BY INCREASING THEM AS NEEDED BASED ON AN INCREASE IN PATIENTS METABOLISM. FAILURE TO ADJUST THE GAS SUPPLY AND THE BLOOD FLOW RATE APPROPRIATELY MAY CAUSE INSUFFICIENT O2 SUPPLY NEEDED OR THE AMOUNT OF THE PATIENT'S GASEOUS METABOLISM." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING EMERGENCY SURGERY THE GAS EXCHANGE DETERIORATED WHILE USING A CAPIOX OXYGENATOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: (1) 4-5 HOURS AFTER THE PROCEDURE STARTED AND DURING PERFUSION, THE GAS EXCHANGE DETERIORATED; (2) THE COMPLETE HEART LUNG MACHINE AND PERFUSION SET WERE REPLACED; (3) A MEDTRONIC OXYGENATOR WAS USED AS PART OF THE NEW PERFUSION SET; (4) THERE WAS NO SIGNIFICANT BLOOD LOSS AS THE BLOOD FROM THE ORIGINAL OXYGENATOR WAS RE-TRANSFUSED; (5) THERE WAS NO SIGNIFICANT DELAY IN PROCEDURE; (6) THE PATIENT RECEIVED AN ARTIFICIAL HEART DURING THIS PROCESS; (8) THE PATIENT WAS TRANSFERRED TO ICU AND LATER EXPIRED; (9) IT IS REPORTED THAT THERE IS NO RELATIONSHIP BETWEEN OXYGENATOR CHANGEOUT AND THE PATIENT'S DEATH; (10) THE PATIENT WAS REPORTED AS HAVING MULTIPLE ORGAN DYSFUNCTIONS/FAILURES OF THE LIVER, LUNG AND KIDNEY.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP #1 FOR MFG. REPORT # 9681834-2014-00066 TO PROVIDE ADDITIONAL INFORMATION REGARDING EVALUATION OF THE RETURNED SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198003 CAPIOX FX OXYGENATOR BLOOD GAS OXYGENATOR DTZ TERUMO CORPORATION, ASHITAKA NA 130416

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death MEDTRONIC OXYGENATOR