BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 22974699 · Received September 4, 2025

    Report

    Report Number
    9681834-2025-00156
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    July 31, 2025
    Report Date
    September 4, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3A: SEX: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: CLINICAL ENGINEER. G4: 510(K) NUMBER: K071494, K130520. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. CONFIRMATION OF THE PROVIDED IMAGE SHOWED THAT, IN THE GAS EXCHANGE SECTION OF THE OXYGENATOR FOLLOWING BLOOD RETRANSFUSION, BOTH RED-STAINED AREAS AND WHITE REGIONS WERE OBSERVED. VISUAL INSPECTION OF THE ACTUAL DEVICE UPON RECEIPT REVEALED NO ANOMALIES SUCH AS BREAKAGE. THE "WHITE PART" DESCRIBED IN THE REPORTED ISSUE COULD NOT BE CONFIRMED DURING THE INSPECTION. AFTER FILLING THE ACTUAL DEVICE WITH A SALINE SOLUTION CONTAINING GLUTARALDEHYDE AND SECURING IT, THE HOUSING WAS REMOVED FOR VISUAL INSPECTION. NO SUBSTANCES, SUCH AS BLOOD CLOTS OR WHITE MATERIAL, WERE FOUND ADHERED TO THE HOUSING. AFTER THE HOUSING OF THE ACTUAL DEVICE WAS REMOVED, A VISUAL INSPECTION OF THE GAS EXCHANGE SECTION WAS PERFORMED. BLOOD CLOTS WERE OBSERVED WITHIN THE COMPONENT. HOWEVER, NO SUBSTANCES RESEMBLING THE "WHITE PART" DESCRIBED IN THE REPORTED ISSUE WERE FOUND ADHERED TO THE GAS EXCHANGE SECTION. AFTER THE FILTER WAS REMOVED FROM THE ACTUAL DEVICE, A VISUAL INSPECTION OF THE GAS EXCHANGE SECTION WAS PERFORMED. BLOOD CLOTS WERE OBSERVED WITHIN THE COMPONENT. NO SUBSTANCES RESEMBLING THE "WHITE PART" DESCRIBED IN THE REPORTED ISSUE WERE FOUND ADHERED TO THE GAS EXCHANGE SECTION. ADDITIONALLY, NO ANOMALIES WERE IDENTIFIED IN THE WINDING CONDITION OF THE FIBER. CONFIRMATION OF THE PUMP RECORDS INDICATED THAT, AT THE START OF EXTRACORPOREAL CIRCULATION, THE BLOOD FLOW RATE WAS 4.24 L/MIN, THE GAS FLOW RATE WAS 1.5 L/MIN, AND THE FRACTION OF INSPIRED OXYGEN (FIO) WAS 40%. IT WAS NOTED THAT MIXED VENOUS OXYGEN SATURATION (SVO) TENDED TO DECREASE AFTER REWARMING BEGAN. AT THAT TIME, THE CIRCULATION CONDITIONS WERE A BLOOD FLOW RATE OF 4.22 L/MIN, A GAS FLOW RATE OF 3.8 L/MIN, AND FIO OF 45%. REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD FOR THE ACTUAL DEVICE REVEALED NO ANOMALIES. ADDITIONALLY, A REVIEW OF THE PAST COMPLAINT FILES CONFIRMED THAT NO OTHER SIMILAR REPORTS WERE FOUND FOR THE PRODUCT ASSOCIATED WITH THE INVOLVED PRODUCT CODE AND LOT NUMBER. BLOOD CLOTS WERE OBSERVED IN THE RETURNED ACTUAL DEVICE. HOWEVER, THE SPECIFIC EVENT DESCRIBED IN THE REPORTED ISSUE COULD NOT BE CONFIRMED, AND THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. BASED ON THE PUMP RECORDS, SEVERAL FACTORS WERE INFERRED AS POSSIBLE CONTRIBUTORS TO GAS EXCHANGE FAILURE, ALTHOUGH A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED. THESE INCLUDED: INSUFFICIENT GAS FLOW RATE AND FRACTION OF INSPIRED OXYGEN (FIO) RELATIVE TO THE PATIENT'S BODY SURFACE AREA (BSA); INCREASED OXYGEN CONSUMPTION DURING REWARMING, WHICH MAY HAVE EXCEEDED THE OXYGENATION CAPACITY, RESULTING IN DECREASED MIXED VENOUS OXYGEN SATURATION (SVO); AND POTENTIAL INTERFERENCE WITH BLOOD-GAS CONTACT DUE TO FACTORS SUCH AS BLOOD CLOTS, LEADING TO POOR OXYGENATION. REFERENCE: INSTRUCTIONS FOR USE (CAPIOX FX25) · BEGIN GAS SUPPLY WITH A VENTILATION-PERFUSION (V/Q) RATIO OF 1 AND FRACTION OF INSPIRED OXYGEN (FIO) AT 100%, THEN ADJUST BASED ON BLOOD GAS MEASUREMENTS. · MEASURE BLOOD GASES AND MAKE NECESSARY ADJUSTMENTS: · TO CONTROL PAO: DECREASE FIO TO LOWER PAO. INCREASE FIO TO RAISE PAO. · TO CONTROL PACO: INCREASE TOTAL GAS FLOW TO LOWER PACO. DECREASE TOTAL GAS FLOW TO RAISE PACO. · DURING PATIENT REWARMING, INCREASE OXYGEN CONCENTRATION, GAS FLOW RATE, AND BLOOD FLOW RATE AS NEEDED TO MATCH THE PATIENT'S RISING METABOLIC DEMANDS. FAILURE TO ADJUST THESE PARAMETERS APPROPRIATELY MAY RESULT IN INSUFFICIENT OXYGEN SUPPLY OR INADEQUATE REMOVAL OF GASEOUS METABOLIC BYPRODUCTS. · DO NOT REDUCE HEPARIN DURING CIRCULATION, AS THIS MAY LEAD TO BLOOD CLOT FORMATION. ADEQUATE HEPARINIZATION IS REQUIRED TO PREVENT CLOTTING WITHIN THE SYSTEM. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT, FOLLOWING COMPLETION OF CIRCULATION, NUMEROUS WHITE SPOTS WERE OBSERVED INSIDE THE OXYGENATOR DURING BLOOD PROCESSING. PARTIAL PRESSURE OF OXYGEN (PCO) WAS MANAGED WITH A TARGET OF 100 MMHG. HOWEVER, REMOVAL OF PARTIAL PRESSURE OF CARBON DIOXIDE (PCO) WAS UNSTABLE, AND THE USER PERCEIVED THAT PCO VALUES WERE ELEVATED. THE EVENT OCCURRED INTRA-OPERATIVELY. THE FINAL PATIENT IMPACT WAS NO HARM. THE REPORTED INCIDENT DID NOT RESULT IN PATIENT INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265159 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX-XRX23361 250611

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown