BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 15135856 · Received July 29, 2022

    Report

    Report Number
    9681834-2022-00152
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    July 13, 2022
    Report Date
    July 29, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. OCCUPATION - CLINICAL ENGINEER. PMA/510(K)- K071572, K130280. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE ACTUAL SAMPLE AS RECEIVED FOUND THAT THE PORT OF THE SAMPLING SYSTEM WHERE THE YELLOW THREE-WAY STOPCOCK WAS LOCATED HAD BEEN FRACTURED AT THE BASE. THE BLUE THREE-WAY STOPCOCK HAD BEEN DISLODGED FROM THE MOUNT. MAGNIFYING INSPECTION OF EACH FRACTURE SURFACE FOUND THAT THE FRACTURE SURFACES WERE SMOOTH OVERALL, WITH A STRIATED PATTERN OBSERVED STARTING FROM THE MOUNT SIDE. NO ELONGATION OF MATERIAL WAS OBSERVED. FROM THIS, IT WAS INFERRED THAT FRACTURED WAS CAUSED BY SOME KIND OF INSTANTANEOUS FORCE. IT IS KNOWN FROM OUR EXPERIENCE THAT WHEN A DIAGONAL UPWARD FORCE IS APPLIED TO THE L- CONNECTOR CONNECTED TO THE BLUE THREE-WAY STOPCOCK SIDE OF THE SAMPLING SYSTEM, BENDING FORCE MAY BE EXERTED TO THE THREE-WAY STOPCOCK AND A BREAK SIMILAR TO THE ACTUAL SAMPLE MAY OCCUR. REVIEW OF THE MANUFACTURING RECORD AND THE PRODUCT-RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION CONFIRMED THAT THERE WERE NOT ANY ANOMALIES IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORTS WITH THE INVOLVED PRODUCT /LOT NUMBER COMBINATION. BASED ON THE INVESTIGATION RESULT, AS A CAUSE OF THIS COMPLAINT, IT IS CONCEIVABLE THAT SOME INSTANTANEOUS FORCE WAS APPLIED TO THE THREE-SAY STOPCOCK, WHICH RESULTED IN THE FRACTURE. HOWEVER, FROM THE STATE OF THE ACTUAL SAMPLE, IT WAS NOT CLARIFIED WHEN SUCH FORCE WAS APPLIED TO THE ACTUAL SAMPLE. RELEVANT IFU REFERENCE: " DO NOT USE IF THE PACKAGE OR DEVICE IS DAMAGED(E.G. CRACKED) OR ANY OF THE PORT CAPS ARE OFF. " " DO NOT USE AN OXYGENATOR AND RESERVOIR THAT LEAKS. REPLACE IT WITH ANOTHER CAPIOX FX25 OXYGENATOR AND RESERVOIR. " 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 THE DURING PRIMING THE INVOLVED CAPIOX DEVICE, IT WAS FOUND THAT SAMPLING SYSTEM WAS LEAKING MEDICAL FLUID. UPON CHECKING IT WAS FOUND THAT THE AREA BETWEEN THE BLUE AND YELLOW COCKS OF SAMPLING SYSTEM HAD BEEN FRACTURED. THE SAMPLING SYSTEM ONLY WAS REPLACED, AND THE PRODUCT WAS USED CONTINUOUSLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE FINAL PATIENT IMPACT WAS NOT HARMED. THE EVENT OCCURRED PRE-TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411884 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA N/A 220131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown