BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX®FX

    MDR report key: 24210178 · Received January 29, 2026

    Report

    Report Number
    9681834-2026-00012
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Date of Event
    January 11, 2026
    Report Date
    January 29, 2026
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350781758
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. E3: OCCUPATION: UNKNOWN. G4: 510(K) NO.: K130280. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST COMPLAINT FILE. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. ASHITAKA WAS INFORMED BY THE LOCAL BRANCH ON 27FEB2026, THAT THE ACTUAL SAMPLE INVOLVED IN THIS COMPLAINT WAS NO LONGER AVAILABLE. CONFIRMATION OF THE PROVIDED IMAGE: IT WAS NOT POSSIBLE TO IDENTIFY THE EVENT LEADING TO AN OBSTRUCTION FROM THE IMAGE. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL DEVICE FOUND NO ANOMALY. NO SIMILAR COMPLAINT WAS RECEIVED. BASED ON THE INVESTIGATION RESULTS, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. SINCE THE ACTUAL DEVICE COULD NOT BE CONFIRMED IN THIS CASE, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "MAKE SURE THE RECIRCULATION CIRCUIT AND THE PURGE LINE ARE NOT CLAMPED, THEN START PUMP AT A LOW SPEED. AFTER CHECKING FOR LEAKAGE OR ANY OTHER PROBLEM, GRADUALLY INCREASE FLOW ABOVE 0.5 L/MIN, BUT DO NOT EXCEED 1.5 L/MIN. VIGOROUSLY RECIRCULATE THE PRIMING FLUID THROUGH THE ENTIRE CIRCUIT UNTIL ALL AIR BUBBLES ARE ELIMINATED. AFTER ALL AIR BUBBLES ARE ELIMINATED, CIRCULATE AT FULL FLOW FOR 10 MIN TO CHECK OXYGENATOR AND TUBING FOR LEAKAGE OR ANY OTHER PROBLEM." "BEFORE INITIATING EXTRACORPOREAL CIRCULATION, BE SURE TO CONFIRM THAT RECIRCULATION LINE AND PURGE LINE ARE CLOSED AND SAMPLING LINE IS ALSO CLOSED WITH ARTERIAL SIDE STOPCOCK. OTHERWISE, OPENING ARTERIAL LINE WILL CAUSE THE BLOOD TO FLOW BACK INTO RESERVOIR THROUGH SAMPLING LINE BECAUSE OF THE PATIENT'S BLOOD PRESSURE AND THE HEAD HEIGHT."

    Description of Event or Problem · 0

    TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING PRIMING, THE ONE-WAY VALVE WAS FOUND TO BE BLOCKED. THE EVENT OCCURRED PRE-TREATMENT; THEREFORE, THERE WAS NO PATIENT INVOLVED OR HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275362 CAPIOX®FX OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX*FX05RE 250122 04987350781758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown