BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 20452768 · Received October 15, 2024

    Report

    Report Number
    9681834-2024-00178
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    September 23, 2024
    Report Date
    October 15, 2024
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    . G4: PMA/510(K): K130280 THE ACTUAL SAMPLE WAS DISCARDED BY THE INVOLVED FACILITY. THE PROVIDED IMAGE OF THE ACTUAL SAMPLE SHOWED THAT THE BLOOD INLET PORT OF THE OXYGENATOR WAS DEFORMED. MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE FOUND NO ANOMALY. NO OTHER SIMILAR REPORT WAS FOUND. ACCORDING TO THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORDS. BASED ON THE PROVIDED IMAGE, IT WAS INFERRED THAT SOME KIND OF EXTERNAL FORCE WAS APPLIED TO THE BLOOD INLET PORT, LEADING TO THE DEFORMATION. HOWEVER, SINCE IT WAS NOT POSSIBLE TO CONFIRM THE ACTUAL SAMPLE, THE CAUSE COULD NOT BE CLARIFIED. RELEVANT INSTRUCTIONS OR USE (IFU) REFERENCE: "IF THE PRODUCT IS DROPPED DURING SET-UP, DO NOT USE IT. REPLACE WITH ANOTHER DEVICE." TERUMO MEDICAL PRODUCTS (TMP) (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

    THE USER FACILITY REPORTED THAT THE BLOOD INLET PORT WAS DEFORMED/KINKED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE EVENT OCCURRED PRE-TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316701 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX*FX05RW 240202 04987350781772

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Male