BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 11606915 · Received April 2, 2021

    Report

    Report Number
    9681834-2021-00044
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    March 9, 2021
    Report Date
    April 2, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER - REQUESTED, NOT PROVIDED. AGE & DATE OF BIRTH - REQUESTED, NOT PROVIDED. PATIENT SEX - REQUESTED, NOT PROVIDED. WEIGHT - REQUESTED, NOT PROVIDED. ETHNICITY - REQUESTED, NOT PROVIDED. RACE - REQUESTED, NOT PROVIDED. UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. OCCUPATION-CLINICAL ENGINEER. PMA/510(K)- K130280. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE COLOR OF THE FIBER ON GAS INLET AND GAS OUTLET SIDES HAD CHANGED IN RED. THERE WAS NOT ANY BREAKAGE IN THE VISIBLE RANGE. THE GAS CHANNEL WAS BLOWN WITH AIR. AS A RESULT, LIQUID FLOWED OUT FROM THE GAS OUTLET PORT SIDE. THE LIQUID FROM THE GAS OUTLET PORT SIDE WAS TESTED WITH PROTEIN TEST PAPER ("URIACE" FROM TERUMO), AND THE PRESENCE OF PROTEIN WAS CONFIRMED. PHYSIOLOGICAL SALINE SOLUTION WAS FLOWED INTO THE ACTUAL SAMPLE BY GRAVITY, AND THEN THE OXYGENATION MODULE WAS INSPECTED WITH NAKED EYE. FORMATION OF BLOOD CLOTS WAS OBSERVED. THE ACTUAL SAMPLE WAS FILLED WITH GLUTARALDEHYDE-CONTAINING PHYSIOLOGICAL SALINE SOLUTION AND FIXED, AND THEN THE HOUSING AND THE FILTER WERE REMOVED. VISUAL INSPECTION OF THE FILTER REVEALED NO FORMATION OF BLOOD CLOTS ON NEITHER SIDE OF THE FILTER. VISUAL INSPECTION OF THE OXYGENATION MODULE FOUND THAT THE FIBER HAD BEEN DISCOLORED PARTIALLY. NO ANOMALY WAS OBSERVED IN THE WINDING STATE OF FIBER. THE FIBER LAYER WAS REMOVED GRADUALLY BY 2 MM-THICKNESS WHILE THE STATE OF FIBER WAS INSPECTED VISUALLY. IT WAS CONFIRMED THAT THE FIBER HAD BEEN DISCOLORED PARTIALLY. NO ANOMALY WAS OBSERVED IN THE WINDING STATE OF THE FIBER. THE HEAT EXCHANGER WAS REMOVED FROM THE OUTER CYLINDER AND INSPECTED WITH NAKED EYE AND MAGNIFIER. THE FLOW PATH WAS NOT OCCLUDED. BOTH SIDES OF THE FILTER REMOVED FROM THE ACTUAL SAMPLE WAS INSPECTED WITH MAGNIFIER. NO ANOMALY WAS OBSERVED IN THE DIAMETER OF THE FILTER MESH. THE FIBER REMOVED FROM THE ACTUAL SAMPLE WAS INSPECTED WITH MAGNIFIER. IT HAD BEEN DISCOLORED PARTIALLY. ELECTRON MICROSCOPIC INSPECTION OF EACH FIBER LAYER FOUND FORMATION OF FIBRIN NET AND ADHESION OF BLOOD CELL COMPONENTS, SUCH AS RBC AND DEFORMED RBC, ON THE OUTER SURFACE. PLASMA COMPONENTS HAD EXUDED TO THE INNER SURFACE OF FIBER. THE FIBER WAS CLEANED, AND THEN THE OUTER AND INNER SURFACE WERE INSPECTED WITH SEM. COMPARED TO A FACTORY-RETAINED SAMPLE, NO DIFFERENCE WAS OBSERVED IN THE STATE OF MICROPORES. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT-RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. IFU STATES: DO NOT USE AN OXYGENATOR AND RESERVOIR THAT LEAKS. REPLACE IT WITH ANOTHER CAPIOX FX25 OXYGENATOR AND RESERVOIR. DO NOT USE THIS PRODUCT FOR A PERIOD IN EXCESS OF SIX HOURS. EXCESSIVE USE FOR OVER SIX HOURS MAY LEAD TO PLASMA LEAK AND THROMBI FORMATION, WHICH MAY COMPROMISE THE GAS EXCHANGE PERFORMANCE. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. IT IS LIKELY THAT FF THE BLOOD PROPERTY IS CHANGED FOR SOME REASON, A SURFACE-ACTIVE SUBSTANCE MAY BE GENERATED IN BLOOD, AND THIS MAY DISRUPT THE RELATION BETWEEN THE SURFACE TENSION OF BLOOD AND THE GAS PRESSURE, WHICH IS BALANCED IN THE MICROPORES OF THE FIBER. SUCH A CONDITION MAY LEAD TO PLASMA LEAK. IN PARTICULAR, FOR THE PATIENTS WITH COMPLICATIONS OR PATIENTS WITH RENAL / HEPATIC FAILURE, PLASMA LEAK TENDS TO OCCUR IN A SHORTER TIME (PLASMA LEAK TENDS TO OCCUR WHEN BLOOD BILIRUBIN LEVEL IS HIGH). HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. THIS REPORT IS FOR THE SECOND DEVICE REPORTED, FOR THE FIRST DEVICE REPORTED THAT WAS USED ON THE SAME PATIENT SEE MDR 9681834-2021-00043. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE WAS USED DURING A NORMAL AVR PROCEDURE. CLAMPING/DECLAMPING WAS REPEATED DUE TO THIN AORTIC WALL. WHILE THE PROCEDURE WAS BEING PROLONGED, PLASMA LEAK OCCURRED (FOAMY LIQUID FLOWED FROM GAS-OUT PORT). THE FIRST OXYGENATOR WAS CHANGED OUT TO CONTINUE THE PROCEDURE. THOUGH THE PROCEDURE COMPLETED, THE SECOND OXYGENATOR ALSO SHOWED A PLASMA LEAK. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504552 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 200302

    Patients

    Seq Age Sex Outcome Treatment
    1