BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 20168452 · Received September 9, 2024

    Report

    Report Number
    9681834-2024-00163
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    August 19, 2024
    Report Date
    September 9, 2024
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350701046
    PMA / PMN Number
    K071494
    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): K130520 THE ACTUAL SAMPLE WAS DISCARDED BY THE INVOLVED FACILITY. PROVIDED IMAGE OF THE ACTUAL SAMPLE SHOWED THAT THE FEMALE LUER PORTS LOCATED AT THE RED AND YELLOW COCKS OF THE SAMPLING SYSTEM HAD BEEN BROKEN OFF AT THE BASE. MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE FOUND NO ANOMALY. PAST COMPLAINT FILE OF THE INVOLVED PRODUCT CODE/LOT NUMBER FOUND NO SIMILAR REPORTS. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORDS. SINCE THE CONDITION OF THE DAMAGED SURFACE OF THE ACTUAL SAMPLE COULD NOT BE CONFIRMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "DO NOT USE IF THE PACKAGE OR DEVICE IS DAMAGED (E.G. CRACKED) OR ANY OF THE PORT CAPS ARE OFF." "IF THE PRODUCT IS DROPPED DURING SET-UP, DO NOT USE IT. REPLACE WITH ANOTHER DEVICE." (B)(4) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE SAMPLING PART WAS DAMAGED AFTER THEY OPENED THE PLASTIC PACKAGE. THE EVENT OCCURRED PRE-TREATMENT. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537387 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX*FX25RW 231130 04987350701046

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male