BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX®FX

    MDR report key: 25058256 · Received May 1, 2026

    Report

    Report Number
    9681834-2026-00081
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    April 6, 2026
    Report Date
    May 1, 2026
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    . E3: OCCUPATION: CLINICAL ENGINEER G4: 510(K) NO: K1300280. VISUAL INSPECTION OF THE ACTUAL DEVICE. THE SAMPLING LINE HAD BEEN FRACTURED AT THE BASE OF THE PORT. NO ANOMALY SUCH AS DAMAGE WAS FOUND IN APPEARANCE IN OTHER PARTS. MAGNIFYING AND ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURED PART AND SIDES OF THE ACTUAL DEVICE. IT WAS FOUND THAT THE FRACTURE SURFACE HAD A SMOOTH SURFACE AND A ROUGH SURFACE. IT HAD NOT BEEN ELONGATED AT THE SIDE. IN ADDITION, NO CONTAMINATION BY FOREIGN MATTERS OR AIR LEADING TO FRACTURE WAS FOUND IN THE FRACTURED PART. SIMULATION TEST: AFTER APPLYING AN INSTANT IMPACT LOAD TO A FACTORY-RETAINED TUBE AND MAKING IT FRACTURED, THE FRACTURED PART AND THE SIDE WERE CONFIRMED WITH AN ELECTRON MICROSCOPE. AS A RESULT, THE FRACTURED PART HAD A SMOOTH SURFACE AND A ROUGH SURFACE, WHICH IS SIMILAR TO THE CONDITION OF ACTUAL DEVICE. IN ADDITION. IT WAS NOT ELONGATED AT THE SIDE, WHICH IS ALSO SIMILAR TO THE CONDITION OF THE ACTUAL DEVICE. AFTER APPLYING AN INSTANT TENSILE LOAD TO A FACTORY-RETAINED TUBE AND MAKING IT FRACTURED, THE FRACTURED PART AND THE SIDE WERE CONFIRMED WITH AN ELECTRON MICROSCOPE. AS A RESULT, THE FRACTURED PART HAD A ROUGH SURFACE THROUGHOUT AND CRUSHED TOWARD THE CENTER OF THE TUBE. IN ADDITION, IT WAS ELONGATED AT THE SIDES. THIS CONDITION WAS CONSIDERED DIFFERENT FROM THAT OF THE ACTUAL DEVICE. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL DEVICE FOUND NO ANOMALY. NO OTHER SIMILAR COMPLAINT WAS RECEIVED. BASED ON THE INVESTIGATION RESULTS, AS ONE OF THE POSSIBILITIES SUGGESTED BY THE CONDITION OF THE ACTUAL DEVICE AND THE SIMULATION TEST RESULTS, IT WAS CONSIDERED POSSIBLE THAT SOME STRONG IMPACT LOAD WAS APPLIED, LEADING TO FRACTURE. ALTHOUGH THE TIMING OF THE FRACTURE IS CONSIDERED TO BE IN TRANSIT FROM SHIPMENT TO ARRIVAL AS THERE IS NO ANOMALY IN MANUFACTURING RECORDS, ETC., IT WAS NOT POSSIBLE TO CLARIFY EXACTLY WHEN IT OCCURRED. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "IF THE PRODUCT IS DROPPED DURING SET-UP, DO NOT USE IT. REPLACE WITH ANOTHER DEVICE." TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. (B)(4) 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 PRIMING, IT WAS OBSERVED LIQUID WAS LEAKING FROM THE SAMPLING LINE OF THE OXYGENATOR. NO SAMPLING LINE WAS ATTACHED TO THE INVOLVED PART AND THE SAMPLING LINE IN QUESTION WAS LOOKED FOR AND FOUND IN THE BOX. THE PROCEDURE OUTCOME WAS NOT REPORTED. IT WAS UNCLEAR WHEN IT WAS DAMAGED. THE EVENT OCCURRED PRE-TREATMENT; THEREFORE, NO PATIENT WAS INVOLVED OR HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167655 CAPIOX®FX OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX-XRZ10602A 251017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown