BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX15 OXYGENATOR

    MDR report key: 22957147 · Received September 3, 2025

    Report

    Report Number
    9681834-2025-00136
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    August 4, 2025
    Report Date
    September 3, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    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) NUMBER: K071494, K130520. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED. NO ANOMALIES SUCH AS BREAKAGE WERE OBSERVED. THE DEVICE WAS FIXED IN A SALINE SOLUTION CONTAINING GLUTARALDEHYDE, AND THE HOUSING AND FILTER WERE REMOVED FOR INSPECTION OF THE GAS EXCHANGE SECTION. NO IRREGULARITIES WERE FOUND IN THE WINDING CONDITION OF THE FIBER. FURTHER INSPECTION WAS CONDUCTED BY REMOVING THE FIBER LAYERS. BLOOD CLOTS WERE OBSERVED ON THE GAS EXCHANGE SECTION, ALTHOUGH THE WINDING CONDITION OF THE FIBER REMAINED NORMAL. THE OUTER CYLINDER WAS REMOVED FROM THE HEAT EXCHANGER, AND BOTH VISUAL AND MAGNIFIED INSPECTIONS WERE PERFORMED. NO OCCLUSION OF THE FLOW CHANNELS OR BLOOD CLOT FORMATION WAS IDENTIFIED IN THE HEAT EXCHANGER. ELECTRON MICROSCOPIC INSPECTION OF THE FIBER REVEALED ADHERENCE OF BLOOD CELL COMPONENTS, INCLUDING RED BLOOD CELLS AND WHITE BLOOD CELLS. REVIEW OF THE MANUFACTURING AND SHIPPING INSPECTION RECORDS FOR THE AFFECTED PRODUCT CODE AND LOT NUMBER SHOWED NO ANOMALIES. NO SIMILAR COMPLAINTS WERE FOUND IN THE HISTORICAL COMPLAINT DATABASE FOR THE SAME PRODUCT CODE AND LOT NUMBER. BASED ON THE INVESTIGATION FINDINGS, BLOOD CLOTS WERE CONFIRMED ON THE FIBER. THE LIKELY CAUSE OF THE EVENT WAS OBSTRUCTION DUE TO CLOT FORMATION; HOWEVER, THE INVESTIGATION DID NOT IDENTIFY A DEFINITIVE CAUSE FOR THE CLOT FORMATION OR ESTABLISH A CAUSAL RELATIONSHIP WITH THE SUSPECTED COLD AGGLUTINATION EVENT. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE - CAPIOX FX25/15: DO NOT REDUCE HEPARIN DURING CIRCULATION, AS THIS MAY RESULT IN BLOOD CLOTTING. ·ADEQUATE HEPARINIZATION OF THE BLOOD IS REQUIRED TO PREVENT CLOTTING WITHIN THE SYSTEM. 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

    THE USER FACILITY REPORTED THAT THE DEVICE WAS USED DURING A PEDIATRIC CARDIOPULMONARY BYPASS PROCEDURE. DURING THE PROCEDURE, AN EVENT CONSISTENT WITH COLD AGGLUTINATION WAS OBSERVED. THE DEVICE CONTINUED TO BE USED, AND THE CASE WAS COMPLETED WITHOUT INTERRUPTION. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED TO PREVENT INJURY. THE PATIENT WAS NOT HARMED. THE EVENT OCCURRED INTRA-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386801 CAPIOX FX15 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX-XRY07856 250408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown