BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF

    MDR report key: 18777328 · Received February 26, 2024

    Report

    Report Number
    9681834-2024-00020
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    January 31, 2024
    Report Date
    February 26, 2024
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DTZ
    UDI-DI
    04987350701121
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED; D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. H6: INVESTIGATION FINDINGS - CODE 3252 IS BASED UPON THE EVALUATION OF USER FACILITY INFORMATION AND THE INVESTIGATION OF THE IMAGES RECEIVED; CODE 3221 IS BASED UPON NO SAMPLE RETURNED. THE ACTUAL SAMPLE WAS DISCARDED BY THE INVOLVED FACILITY; HOWEVER, AN IMAGE WAS PROVIDED. FROM THE PROVIDED IMAGE, IT WAS CONFIRMED THAT THE PURGE LINE OF OXYGENATOR WAS FRACTURED FROM THE PORT. WE HAVE EXPERIENCED THAT THE SIMILAR FRACTURE MAY HAVE BEEN OCCURRED WHEN MOMENTARY EXTERNAL FORCE WAS APPLIED WHILE THE PRODUCT WAS COLD. THE LOCAL TEMPERATURE FROM FEBRUARY 2023 TO THE DATE OF OCCURRENCE ((B)(6) 2024) WAS INVESTIGATED. IT WAS FOUND THAT THE MINIMUM TEMPERATURE WAS BELOW ZERO. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE FOUND NO ANOMALY. ONE SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT (PPR-23-1941-1) WAS FOUND. IN ADDITION, NO ACTUAL SAMPLE FOR PPR-23-1941-1 WAS ALSO AVAILABLE. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORDS OF ACTUAL PRODUCT. AS A POSSIBLE CAUSE OF OCCURRENCE, BASED ON OUR PAST EXPERIENCE, IT WAS INFERRED THAT AFTER THE PRODUCT WAS SHIPPED FROM THE FACTORY, DURING THE DISTRIBUTION PROCESS IN THE COLD SEASON, MOMENTARY FORCE WAS APPLIED TO THE PRODUCT WHILE IT WAS COOLED, CAUSING IT TO FRACTURE. HOWEVER, SINCE THE CONDITION OF DAMAGE ON THE ACTUAL PRODUCT COULD NOT BE CONFIRMED, IT WAS NOT POSSIBLE TO IDENTIFY THE CAUSE OF THIS CASE. TERUMO MEDICAL PRODUCTS (TMP) (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

    TERUMO MEDICAL RECEIVED AN EMAIL VIA DISTRIBUTOR MEDILANS FROM KEMEROVO SCIENTIFIC RESEARCH INSTITUTE ON THE BROKEN OXYGENATORS. THE PROBLEM WAS DETECTED WHEN UNPACKING OXYGENATORS FROM THE OUTER PACKAGE. ON TWO SAMPLES FROM THE SAME BOX, THERE WAS A BROKEN PURGE LINE PORT AND DISCONNECTED PURGE LINE AT THE PLACE OF ITS CONNECTION WITH OXYGENATOR BODY. ACCORDING TO CHIEF OF ANESTHESIOLOGY DEPARTMENT, THIS COULD NOT BE OCCURRED DURING TRANSPORTATION (NO VISIBLE SIGNS) OR REMOVING OXYGENATOR FROM THE BOX. THE VENT OCCURRED PRE-TREATMENT. THERE WAS NO PATIENT INVOLVED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306381 CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO MEDICAL CORPORATION N/A 221215 04987350701121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown