BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX®FX

    MDR report key: 24303564 · Received February 10, 2026

    Report

    Report Number
    9681834-2026-00017
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    January 23, 2026
    Report Date
    February 10, 2026
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350781772
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: NO PATIENT INVOLVEMENT. A2: AGE & DATE OF BIRTH: NO PATIENT INVOLVEMENT. A3: PATIENT SEX: NO PATIENT INVOLVEMENT. A4: WEIGHT: NO PATIENT INVOLVEMENT. A5: ETHNICITY: NO PATIENT INVOLVEMENT. A6: RACE: NO PATIENT INVOLVEMENT. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E1: INITIAL REPORTER NAME: UNKNOWN . E1: ESTABLISHMENT NAME: (B)(6). E1: PHONE NUMBER: UNKNOWN. E3: OCCUPATION: TECHNOLOGIST. G4: 510(K) NO.: K130280. NO ACTUAL DEVICE WAS RETURNED. CONFIRMATION OF THE PROVIDED IMAGES AND VIDEOS: IT WAS FOUND THAT THE OXYGENATOR BLOOD IMPORT WAS DEFORMED FROM THE OUTSIDE TOWARD THE INSIDE. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL DEVICE FOUND NO ANOMALY. NO OTHER SIMILAR ISSUE HAS BEEN REPORTED. ACCORDING TO THE INVESTIGATION RESULTS, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORDS. BASED ON THE PROVIDED IMAGE, IT WAS INFERRED THAT SOME KIND OF EXTERNAL LOAD WAS APPLIED TO THE BLOOD INLET PORT, LEADING TO THE DEFORMATION. HOWEVER, SINCE THE ACTUAL DEVICE COULD NOT BE CONFIRMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF THE OCCURRENCE. THE INSTRUCTIONS FOR USE (IFU) FOR CAPIOX FX05 INDICATES AS FOLLOWS: "IF THE PRODUCT IS DROPPED DURING SET-UP, DO NOT USE IT. REPLACE WITH ANOTHER DEVICE." 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 MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE OXYGENATOR'S BLOOD OUTLET HAD DEFORMATION. THE EVENT OCCURRED PRE-TREATMENT; THEREFORE, NO PATIENT WAS INVOLVED OR HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75142 CAPIOX®FX OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX*FX05RW 250204 04987350781772

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown