BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX15 OXYGENATOR

    MDR report key: 23646828 · Received November 25, 2025

    Report

    Report Number
    9681834-2025-00221
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    October 24, 2025
    Report Date
    November 25, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350701169
    PMA / PMN Number
    K071494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE A CORRECTION TO SECTION A3A. SEX AND H1. MALE WAS INADVERTENTLY SUBMITTED IN SECTION A3B., THE PATIENT SEX COULD NOT BE OBTAINED. THE INITIAL MDR CAPTURED "DEATH" IN SECTION H1; HOWEVER, "SERIOUS INJURY" IS CORRECT.

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: DISTRIBUTOR. G4: 510(K) NO.: K130520. THE ACTUAL DEVICE WAS NOT AVAILABLE; THEREFORE, THE ACTUAL DEVICE WILL NOT BE RETURNED FOR EVALUATION. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO SIMILAR COMPLAINT WAS RECEIVED REGARDING THE INVOLVED PRODUCT CODE AND LOT. BASED ON THE INVESTIGATION RESULTS, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORDS. SINCE THE ACTUAL DEVICE COULD NOT BE CONFIRMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF THE OCCURRENCE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: THE IFU (CAPIOX FX15) OF ASHITAKA FACTORY HAS THE FOLLOWING WARNINGS AND CAUTION REGARDING AIR MIXING: "PRESSURE IN THE BLOOD PHASE SHOULD ALWAYS BE HIGHER THAN THAT IN THE GAS PHASE TO PREVENT GASEOUS EMBOLI ENTERING THE BLOOD PHASE." "THE GAS FLOW RATE SHOULD NOT EXCEED 15L/MIN. EXCESSIVE GAS FLOW RATE WILL BRING ABOUT PRESSURE INCREASE IN THE GAS PHASE, ALLOWING GASEOUS EMBOLI TO ENTER THE BLOOD PHASE." (B)(4) (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 · 0

    TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. AN ADULT PATIENT WITH PERIPHERAL CANNULATION AND ASSISTED VENOUS DRAINAGE HAD BEEN ON PUMP SUPPORT FOR THREE HOURS. THE MEDICAL TEAM WAS PREPARING TO WEAN THE PATIENT FROM THE PUMP WHEN THE OXYGENATOR BEGAN TO FOAM, CAUSING THE TUBING TO POP OUT. THE OXYGENATOR BECAME PRESSURIZED, RELEASING BUBBLES INTO THE ARTERIAL LINE. THE OXYGENATOR WAS REPLACED, AND RETROGRADE PERFUSION WAS PERFORMED TO REMOVE THE BUBBLES THAT HAD ENTERED. THE PATIENT'S CONDITION WAS ALREADY POOR, AND HE DID NOT SURVIVE. THERE HAD BEEN A CHANGE OF OPERATING ROOM, AND COMMUNICATION INDICATED THAT THE WALL OUTLETS WERE MALFUNCTIONING. THEY WERE PRESSURIZING DUE TO WATER ACCUMULATION OR BLOWING AIR INSTEAD OF ASPIRATING. THIS WAS BELIEVED TO HAVE CAUSED THE DEVICE MALFUNCTION. THE USER ASSUMED THAT THE BLEEDING ISSUE WAS RELATED TO A PROBLEM WITH THE AIR INTAKES RATHER THAN PROPER ASPIRATION. THE OXYGENATOR WAS REPLACED, WHICH ADDED APPROXIMATELY FIVE MINUTES TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1945765 CAPIOX FX15 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX*FX15RW30 241119 04987350701169

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death