BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPIOX FX25

    MDR report key: 25081820 · Received May 5, 2026

    Report

    Report Number
    9681834-2026-00089
    Event Type
    Death
    Date Received
    May 5, 2026
    Date of Event
    April 9, 2026
    Report Date
    May 5, 2026
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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) NO.: K130520. VISUAL INSPECTION OF THE ACTUAL DEVICE UPON RECEIPT: A BLOOD CLOT WAS FOUND NEAR THE 3/8 PORT OF THE RESERVOIR (INSIDE THE CARDIOTOMY FILTER). NO ANOMALY SUCH AS DAMAGE WAS FOUND. VISUAL INSPECTION OF THE DEFOAMER OF THE VENOUS FILTER AND DEFOAMING AGENT AFTER DISASSEMBLING THE ACTUAL DEVICE: NO SIGNIFICANT BLOOD CLOTS WERE OBSERVED ON THE INNER SURFACE OF THE DEFOAMER OF THE VENOUS FILTER OR ON THE DEFOAMING AGENT. VISUAL INSPECTION OF THE CR FILTER AND THE DEFOAMING AGENT REMOVED FROM THE ACTUAL DEVICE: THE FORMATION OF BLOOD CLOTS WAS OBSERVED ON THE SURFACE OF THE DEFOAMING AGENT IN CR FILTER. REVIEWING THE PUMP RECORD, THE FOLLOWING WAS CONFIRMED: AFTER CHECKING THE MEDICATION ADMINISTERED FROM PUMP-ON TO BEFORE CIRCUIT CHANGE, IT WAS CONFIRMED THAT VOLBEN WAS USED AT 13:08. AS A RESULT OF REVIEWING THE PACKAGE INSERT OF VOLBEN, IT WAS NOT POSSIBLE TO DETERMINE THE CAUSAL RELATIONSHIP BETWEEN THE USE OF VOLBEN AND THE OBSTRUCTION. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL DEVICE FOUND NO ANOMALY. NO OTHER SIMILAR REPORT WAS FOUND. BASED ON THE INVESTIGATION RESULTS, BLOOD CLOT WAS OBSERVED ON THE DEFOAMING AGENT IN CR FILTER OF THE ACTUAL DEVICE. THE CAUSE OF THE OBSTRUCTION INSIDE THE CR FILTER MAY HAVE BEEN RELATED TO THE FORMATION OF BLOOD CLOTS INSIDE THE FILTER DUE TO THE ASPIRATION OF BLOOD CLOTS FROM THE SURGICAL FIELD OR BLOOD WITH ACTIVATED COAGULATION FACTORS, BUT IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF THE OCCURRENCE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "IF BLOOD ENTERING THE CARDIOTOMY RESERVOIR FILTER INLET APPEARS TO SPILL OVER VERSUS ENTERING THE FILTER THIS MAY INDICATE THAT THE FILTER IS CLOGGED. DISCONTINUE USING THE CARDIOTOMY RESERVOIR FILTER. REPLACE THE RESERVOIR. THE BLOOD FLOW INTO THE CARDIOTOMY FILTER SHOULD NOT EXCEED THE RATE OF 5 L/MIN. EXCESSIVE BLOOD FLOW RATE MAY INCREASE THE PRESSURE IN THE CARDIOTOMY FILTER, RESULTING IN BACK-FLOW INTO ANY SOLUTION OR BLOOD ADMINISTRATION LINE CONNECTED TO THE HARDSHELL RESERVOIR." TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING THE SURGERY FOR AORTIC ANEURYSM, CR IN THE RESERVOIR WAS OBSTRUCTED. ECMO WAS INTRODUCED AND CIRCUIT WAS ONCE WEANED OFF. A NEW PRE-CONNECTED CIRCUIT WAS PREPARED AND ATTEMPTED AGAIN. DURING EXTRACORPOREAL CIRCULATION, A STATE OF MASSIVE BLEEDING PERSISTED, AND LARGE AMOUNT OF INFUSION AND BLOOD TRANSFUSION WAS NEEDED. AFTER THE PATIENT WAS TRANSFERRED TO ICU FROM THE OPERATING ROOM AND S/HE WAS CONFIRMED DEAD. DETAILS AT EXTRACORPOREAL CIRCULATION: THE PUMP WAS ON AT 12:41 AND AORTA WAS CLAMPED AT 12:45. DURING AORTIC ANEURYSM RESECTION, A LARGE HEMATOMA WAS FOUND IN THE ANEURYSM AND WAS REMOVED. THE CELL SAVER WAS USED FOR BLOOD CONSERVATION AT FIRST; HOWEVER, SWITCHED TO SUCTION OPERATION AT CR FILTER SIDE DUE TO MASSIVE BLEEDING. SINCE THE INFUSION BAG AT THE UPPER PART OF THE RESERVOIR EXPANDED DUE TO THE POSITIVE PRESSURE OF CR, THE CR SIDE BECAME SOLIDIFIED, MAKING IT IMPOSSIBLE TO ADD INFUSION. THEREFORE, ECMO WAS INTRODUCED AND THE PUMP WAS STOPPED. WHILE ECMO WAS RUNNING, THE CIRCUIT WAS RENEWED TO THE SAME PRE-CONNECTED CIRCUIT (CX-XRX35002) AND EXTRACORPOREAL CIRCULATION RESTARTED AT 13:58. UNCLAMPED AT 16:27, THE PUMP WAS OFF AT 18:15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70442 CAPIOX FX25 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX-XRX35002 260116

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other| D CELL SAVER.| ECMO.