BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 6709856 · Received July 13, 2017

    Report

    Report Number
    9681834-2017-00138
    Event Type
    Malfunction
    Date Received
    July 13, 2017
    Date of Event
    June 14, 2017
    Report Date
    July 13, 2017
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350781772
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. FOR THIS REASON CODE 20 WAS USED IN THE CONCLUSIONS SECTION OF H6. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION WAS CONDUCTED WITH NO RELEVANT FINDINGS. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022. 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 · 0

    THE USER FACILITY REPORTED THE CAPIOX DEVICE DID NOT PERFORM OXYGENATION DURING A PROCEDURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: REPORTED DURING PEDIATRIC OPERATION ON A PATIENT UNDERGOING A PROCEDURE CALLED (B)(6); OPERATION IS CARRIED IN 36° TEMPERATURE; THE HEART LUNG MACHINE WAS INSTALLED, IN ADDITION HEMOFILTRATION AND VACUUM SYSTEM AS NEEDED IS DONE FOR ALL PEDIATRIC SURGERIES; THE SYSTEM INCLUDED SUPPLY OF PLASMA DOSE, BLOOD AND OTHER DRUGS BY THE PROTOCOL; BY THE PROTOCOL WE OPEN THE OXYGENATION SYSTEM AND CHECKED THE PRIME LOTION, A TEST WAS DONE AND A VALUE OF PO2=423 MMHG. WAS ACCEPTED; AT 10:26 THE PATIENT WAS CONNECTED TO THE HEART LUNG MACHINE, AND FIRST SAMPLE WAS TAKEN AT 10:39 AND RECEIVED VALUES OF PO2 297,PCO2 49,HCT 38 SHOWING THE HEART LUNG MACHINE FUNCTIONED FINE; AT 10:39 A SECOND TEST SHOWING RESULTS OF PO2 228, PCO2 39, CT 40, K+ 4.0; DURING CHECKS OF THE SYSTEM AND UPON THE RESULTS IT WAS FOUND THAT AT 10:50 A POTASSIUM VALUE OF 9.2 WAS FOUND, THE BLOOD DOSE WAS DATED 12.06.2017; THIS VALUE WAS IMMEDIATELY REPORTED TO THE ANAESTHESIA AND AS A REACTION FOR THE POTASSIUM RAISE THE PATIENT RECEIVED CALTIUM GLOGONAT AND 155ML OF SALINE IN FAVOUR OF WASHING THE BLOOD VIA THE SYSTEM; 10:55 HEMOLISION AT THE HEMOFILTRATION SYSTEM; PO2 133, PCO2 42, HCT 40 AT 10:58 ANOTHER TEST WAS DONE AND THE POTASSIUM VALUE WAS STILL HIGH; AT 11:02 ANOTHER TEST WAS DONE AND WE RECEIVED THE FOLLOWING VALUES : -K+ 8.8, PO2 146, PCO2 38, HCT 47; IN THIS STAGE WE CONTINUE WITH THE BLOOD WASH PROCESS TO LOWER THE POTASSIUM LEVEL; DURING THE PROCESS IT WAS NOTICED THE ARTERIAL BLOOD WAS TOO DARK AND AT 11:13 TEST THE FOLLOWING VALUES WERE RECEIVED: PO2 46, PCO2 56, K+ 6.8, HCT 42; ORIGINAL LEVEL WAS RAISED FROM 70% TO 80%; THE COLOR DID NOT CHANGED, DUE TO THOSE EXCEPTIONAL LEVELS IT WAS RAISED TO 100% FIO2; AT 11:17 THE SURGEON WAS NOTIFIED OF THE FOLLOWING VALUES: PO2 41, PCO2 54, K+ 6.4,HCT 49 AND IT WAS DIFFICULT TO OXYGENATE THE PATIENT; AS A RESULT IT WAS DECIDED BY THE DOCTOR TO RESUSCITATE THE CHILD AND GO OFF THE PUMP AT 11:18, 11:18 PUMP OFF; AND THE PATIENT WAS NOT HARMED.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. VISUAL INSPECTION FOUND NO ANOMALIES WHICH WOULD RELATE TO A GAS LEAK OR INSUFFICIENT GAS TRANSFER PERFORMANCE. THE ACTUAL SAMPLE, AFTER HAVING BEEN RINSED AND DRIED WAS TESTED FOR ITS GAS TRANSFER PERFORMANCE IN ACCORDANCE TO THE FACTORY'S SHIPPING INSPECTION PROTOCOL. BOVINE BLOOD WAS CIRCULATED IN THE OXYGENATOR MODULE UNDER CERTAIN CONDITIONS. NO ANOMALIES WERE REVEALED IN THE GAS TRANSFER PERFORMANCE OF THE ACTUAL SAMPLE, WITH THE OBTAINED VALUES MEETING THE FACTORY SPECIFICATIONS. THE REPORT FROM THE PERFUSIONIST WAS REVIEWED. THE CUSTOMER DID NOT NOTICE ANY ANOMALIES IN THE GAS TRANSFER PERFORMANCE IMMEDIATELY AFTER THE INITIATION OF THE EXTRACORPOREAL CIRCULATION. DURING THE CIRCULATION, HEMOLYSIS AND AN INCREASE IN POTASSIUM VALUE WERE NOTED. WITH AN INCREASED FIO2, PAO2 WOULD NOT INCREASE. FROM THIS INFORMATION, IT IS ASSUMABLE THE INCREASE IN THE POTASSIUM VALUE WAS DUE TO THE OCCURRENCE OF HEMOLYSIS. THE CAUSE OF THE OCCURRENCE OF HEMOLYSIS, HOWEVER, CANNOT BE IDENTIFIED FROM THE AVAILABLE INFORMATION. FROM THE FACT THAT THE INCREASED FIO2 DID NOT HELP TO INCREASE PAO2, IT IS ASSUMABLE THAT SOME FACTOR(S) HINDERED THE GASES FROM BEING TRANSFERRED ADEQUATELY. WITH NO INFORMATION ABOUT THE CIRCULATION CONDITIONS PROVIDED, THE CURSE OF THE POOR GAS TRANSFER PERFORMANCE CANNOT BE DETERMINED. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE INVESTIGATION RESULTS VERIFIED THE ACTUAL SAMPLE WAS NORMAL PRODUCT WITH NO ISSUE IN THE GAS TRANSFER PERFORMANCE. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTIONS-FOR-USE (IFU) WITH STATEMENTS SUCH AS THE FOLLOWING: MEASURE BLOOD GASES AND MAKE NECESSARY ADJUSTMENTS AS FOLLOWS. CONTROL PAO2 BY CHANGING CONCENTRATION OF OXYGEN IN VENTILATING GAS USING GAS BLENDER. TO DECREASE PAO2, DECREASE FIO2. TO INCREASE PAO2, INCREASE FIO2. 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 05 L/MIN FOR 10 SECONDS. DO NOT REPEAT THIS FLUSHING TECHNIQUE, EVEN IF OXYGENATOR PERFORMANCE IS NOT IMPROVED. UPON PATIENT REWARMING, ADJUST O2 CONCENTRATION, GAS FLOW RATE AND BLOOD FLOW RATE BY INCREASING THEM AS NEEDED BASED ON AN INCREASE IN PATIENT'S 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491620 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 160715 04987350781772

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO