BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 19570448 · Received June 19, 2024

    Report

    Report Number
    9681834-2024-00102
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    May 22, 2024
    Report Date
    June 19, 2024
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: NO PATIENT INVOLVEMENT. A2: AGE OR DATE OF BIRTH: NO PATIENT INVOLVEMENT. A3A: SEX: NO PATIENT INVOLVEMENT. A3B: GENDER: 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. E3: OCCUPATION: CLINICAL ENGINEER. G4: 510K NUMBER: K130520. 1.VISUAL INSPECTION OF THE ACTUAL SAMPLE UPON RECEIPT IT WAS CONFIRMED THAT THE PURGE LINE TUBE HAD BEEN CRUSHED NEAR THE TIP CONNECTOR. 2. MAGNIFYING INSPECTION OF THE CRUSHED PART IT WAS FOUND THAT FIVE LINEAR CONTACT MARKS HAD BEEN CAUSED AT REGULAR INTERVALS ON THAT AREA. 3. CONFIRMATION OF THE PATENCY OF LUMEN AT THE CRUSHED PART THE SALINE SOLUTION PASSED THROUGH IT SHOWING THAT THE LUMEN WAS NOT COMPLETELY OCCLUDED. 4. CONFIRMATION OF THE PACKAGING STATUS USING RETENTION SAMPLES THE CRUSHED PART OF THE TUBE WAS FOUND TO HAVE BEEN LOCATED ON THE UNDERSIDE OF THE OXYGENATOR. AS THE HOUSING AT THE GAS-IN SIDE OF THE OXYGENATOR HAS FIVE CONVEX PARTS, IT WAS THOUGHT THAT THE CONTACT MARKS WERE CAUSED WHEN THE TUBE WAS SANDWICHED BETWEEN THE OXYGENATOR AND THE CUSHIONING MATERIAL. 5. REVIEW OF THE MANUFACTURING RECORD AND SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE, NO ANOMALY WAS FOUND IN THEM. 6. A SEARCH OF THE PAST COMPLAINT FILE OF THE INVOLVED PRODUCT CODE AND LOT# NO OTHER SIMILAR REPORT WAS FOUND. 7. MANUFACTURING DATE: DECEMBER 15, 2023. 8. CAUSE OF OCCURRENCE/CONCLUSION IN THIS CASE, IT WAS THOUGHT THAT PACKAGING WAS CARRIED OUT WITH THE TUBE SANDWICHED BETWEEN THE OXYGENATOR AND THE CUSHIONING MATERIAL DURING PACKAGING WORK FOR THE PRODUCT IN QUESTION, AFTER THAT THE TUBE SOFTENED DUE TO HEAT LOAD DURING STERILIZATION, AND THEN THE CRUSHED SHAPE WAS FIXED. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "MAKE SURE THE RECIRCULATION CIRCUIT AND THE PURGE LINE ARE NOT CLAMPED, THEN START PUMP AT A LOW SPEED. AFTER CHECKING FOR LEAKAGE OR ANY OTHER PROBLEM, GRADUALLY INCREASE TO FULL FLOW. DO NOT EXCEED 7 L/MIN FLOW RATE. VIGOROUSLY RECIRCULATE THE PRIMING FLUID THROUGH THE ENTIRE CIRCUIT UNTIL ALL AIR BUBBLES ARE ELIMINATED. CHECK OXYGENATOR AND TUBING FOR LEAKAGE OR ANY OTHER PROBLEM. AFTER ALL AIR BUBBLES ARE ELIMINATED, CIRCULATE AT FULL FLOW FOR 10 MIN TO CHECK OXYGENATOR AND TUBING FOR LEAKAGE OR ANY OTHER PROBLEM.". 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 THE PURGE LINE WAS FOUND CRUSHED UNNATURALLY WHEN THE ACTUAL SAMPLE WAS OPENED FROM THE PACKAGE AS IN THE USUAL MANNER. ANOTHER ONE OF THE SAME TYPE WAS TAKEN AND USED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672843 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO MEDICAL CORPORATION N/A 231215

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown