BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 18592568 · Received January 26, 2024

    Report

    Report Number
    9681834-2023-00280
    Event Type
    Malfunction
    Date Received
    January 26, 2024
    Date of Event
    December 26, 2023
    Report Date
    January 26, 2024
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DTZ
    UDI-DI
    04987350701046
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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. E2: HEALTH PROFESSIONAL: UNKNOWN. E3: OCCUPATION: UNKNOWN. G4: PMA/510(K): K071494, K130520. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL PRODUCT FOUND NO ANOMALY. NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT# WAS FOUND. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. SINCE THE ACTUAL SAMPLE COULD NOT BE OBTAINED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: - DO NOT USE AN OXYGENATOR AND RESERVOIR THAT LEAKS. REPLACE IT WITH ANOTHER CAPIOX FX25 OXYGENATOR AND RESERVOIR. - 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. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING CHECKING BEFORE USE IN O.T. LEAKAGE WAS FOUND IN THE OXYGENATOR. THE OXYGENATOR WAS REPLACED WITH NEW ONE. THE EVENT OCCURRED PRE-TREATMENT. THERE WAS NO PATIENT INVOLVEMENT THEREFORE A PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798946 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO MEDICAL CORPORATION N/A 230427 04987350701046

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown