BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25

    MDR report key: 19169792 · Received April 23, 2024

    Report

    Report Number
    9681834-2024-00063
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    March 26, 2024
    Report Date
    April 23, 2024
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DTZ
    UDI-DI
    04987350701046
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: TECHNOLOGIST. G4: 510K #: K130520. 1. INVESTIGATION RESULTS: 1.1 VISUAL INSPECTION OF THE ACTUAL SAMPLE. - IT WAS CONFIRMED THAT THE PURGE LINE HAD BEEN FRACTURED AT THE CONNECTION WITH THE PORT AT THE TOP OF THE OXYGENATOR. 1.2 MAGNIFYING AND ELECTRON MICROSCOPIC INSPECTIONS OF THE FRACTURE SURFACE OF ACTUAL SAMPLE. - IT WAS FOUND THAT THE FRACTURE SURFACE HAD A SMOOTH SURFACE AND A ROUGH SURFACE. FROM THIS, IT WAS INFERRED THAT THE FRACTURE WAS CAUSED BY MOMENTARY FORCE. THERE WAS NO CONTAMINATION OF FOREIGN MATTER OR AIR LEADING TO FRACTURE. - THE HEIGHT OF TRACE OF SOLVENT ON THE TUBE SURFACE WAS CONFIRMED TO BE EQUIVALENT TO THAT OF A CURRENT PRODUCT SAMPLE. 1.3 A PART OF THE PURGE LINE OF THE ACTUAL SAMPLE WAS CUT, AND MAGNIFYING INSPECTION OF THE CROSS SECTION OF TUBE WAS PERFORMED. - NO ANOMALY SUCH AS UNEVEN WALL THICKNESS WAS FOUND. - THE INNER AND OUTER DIAMETERS OF THE TUBE WERE MEASURED, AND NO DIFFERENCES WERE FOUND IN COMPARISON WITH THOSE OF A CURRENT PRODUCT. 2. SIMULATION TEST: BASED ON OUR EXPERIENCE, WE ARE AWARE THAT A SIMILAR FRACTURE MAY OCCUR WHEN MOMENTARY EXTERNAL FORCE IS APPLIED WHILE THE PRODUCT IS IN A COOLED STATE. REGARDING THE PERIOD FROM THE MONTH OF MANUFACTURE (OCTOBER 2023 BASED ON THE SERIAL NUMBER OF THE ACTUAL SAMPLE) TO THE MONTH OF OCCURRENCE (MARCH 2024), THE TEMPERATURE IN THE INVOLVED AREA WAS INVESTIGATED. IT WAS FOUND THAT THE MINIMUM TEMPERATURE WAS BELOW ZERO. ASSUMING THAT THE FRACTURE OCCURRED DURING DISTRIBUTION OR STORAGE, A TEST SAMPLE WAS COOLED AND THEN EXPOSED TO MOMENTARY SHOCK FORCE. IT WAS OBSERVED THAT A PART OF THE TUBE MAY BREAK AT THE CONNECTION WITH THE PRODUCT. ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURE SURFACE OF THE TEST SAMPLE FOUND THAT ITS CONDITION WAS SIMILAR TO THAT OF THE ACTUAL SAMPLE. (THE TEST CONDITIONS WERE SET ARBITRARILY.). 3. HISTORY INVESTIGATION: 3.1 THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE - NO ANOMALY WAS FOUND. 3.2 PAST COMPLAINT FILE OF THE INVOLVED PRODUCT CODE/LOT# - NO OTHER SIMILAR REPORT WAS FOUND. 3.3 MANUFACTURING DATE: OCTOBER 19, 2023. 4. CAUSE OF OCCURRENCE/CONCLUSION: BASED ON THE INVESTIGATION RESULT, AS A POSSIBLE CAUSE OF OCCURRENCE, THE FOLLOWING FACTOR WAS INFERRED FROM THE CONDITION OF THE FRACTURE SURFACE OF ACTUAL SAMPLE AND THE SIMULATION TEST RESULT. HOWEVER, IT WAS NOT POSSIBLE TO CLARIFY WHEN THE FRACTURE OCCURRED. THE PRODUCT IN QUESTION, WHICH WAS IN A COOLED STATE DUE TO THE DISTRIBUTION IN THE COLD SEASON OR EFFECT OF STORAGE ENVIRONMENT, MAY HAVE BEEN SUBJECTED TO SOME STRONG SHOCK FORCE DURING BEING HANDLED, LEADING TO THE FRACTURE. RELEVANT INSTRUCTIONS FOR 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. 2243441 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 THERE WAS LEAKAGE, SAMPLING TUBE FRACTURE. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329975 CAPIOX FX25 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO MEDICAL CORPORATION N/A 231019 04987350701046

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female