BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX RX OXYGENATOR

    MDR report key: 8330506 · Received February 12, 2019

    Report

    Report Number
    9681834-2019-00010
    Event Type
    Malfunction
    Date Received
    February 12, 2019
    Date of Event
    January 15, 2019
    Report Date
    February 12, 2019
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350769572
    PMA / PMN Number
    K040210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE SAMPLING LINE TUBE HAD COME OFF AT THE JOINT TO THE PORT ON THE RESERVOIR. THE SAMPLING LINE TUBE WAS NOTED TO HAVE BEEN PLUGGED. IT IS MOST LIKELY THAT THIS DAMAGE IS THE CAUSE OF THE REPORTED LEAK. THE ACTUAL SAMPLE WAS RINSED AND THE PLUG OF THE PORT WAS REMOVED. SUBSEQUENT MAGNIFYING AND ELECTRON MICROSCOPIC INSPECTIONS OF THE CUT CROSS-SECTION OF THE BROKEN SAMPLING LINE TUBE REVEALED THAT THE SMOOTH SURFACE AND ROUGH SURFACE EXISTED THERE, WITH THE GENERATION OF SOME STREAKS NOTED ON THE SMOOTH SURFACE. THE STREAKS IMPLY THAT THE BREAK HAS DEVELOPED ON THE TUBE IN THE DIRECTION THE STREAKS RUN. REPRODUCTIVE TESTING WAS PERFORMED; BASED ON THE INFORMATION THAT THE REPORTED LEAK WAS NOT FOUND DURING PRIMING BUT FOUND AT THE START OF CPB, THE FOLLOWING HYPOTHESIS WAS INFERRED: THE SAMPLING LINE TUBE OF THE ACTUAL SAMPLE WAS HIT WITH SOME TOOL, SUCH AS FORCEPS, AT ITS JOINT WITH THE PORT DURING THE CIRCULATION. BASED ON THE HYPOTHESIS, THE REPRODUCTIVE TEST WAS CONDUCTED AS FOLLOWS. A FACTORY-RETAINED PRODUCT SAMPLE WAS EXPOSED TO EXCESSIVE SHOCK FORCE BY BEING HIT WITH FORCEPS AT THE JOINT OF THE SAMPLING LINE TUBE AND THE PORT ON THE RESERVOIR. THE SAMPLING LINE TUBE BECAME BROKEN. ELECTRON MICROSCOPIC INSPECTION FOUND THAT THE BREAK CROSS-SECTION PRESENTED THE BREAK CONFIGURATION WHICH WAS VERY SIMILAR TO THAT OF THE ACTUAL SAMPLE. REVIEW OF DEVICE HISTORY RECORDS AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT/LOT# COMBINATION WAS CONDUCTED WITH NO RELEVANT FINDINGS. IFU STATES: DO NOT USE AN OXYGENATOR AND RESERVOIR THAT LEAKS. RECIRCULATE THE PRIMING SOLUTION AT A RATE OF 4L/MIN OR HIGHER TO FACILITATE AIR REMOVAL. FAILURE TO REMOVE AIR FROM THE OXYGENATOR MAY RESULT IN SERIOUS INJURY TO THE PATIENT. USE CAUTION WHEN REMOVING AIR DURING PRIMING AND PERFUSION. EXCESSIVE SHOCK TO THE DEVICE - ESPECIALLY WITH HARD OBJECTS - CAN CAUSE DAMAGE TO THE DEVICE. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE INVESTIGATION RESULT, IT IS LIKELY THAT THAT ACTUAL SAMPLE LEAKED AT THE SAMPLING LINE TUBE WHICH HAD BEEN ALMOST BROKEN AT ITS JOINT TO THE PORT ON THE RESERVOIR. AS A CAUSE OF THE BREAK ON THE SAMPLING LINE TUBE, FROM THE INFORMATION THAT THE CUSTOMER DID NOT FIND THE LEAK DURING PRIMING AND FROM THE STATE OF THE CUT CROSS-SECTION OF THE BROKEN SAMPLING LINE TUBE OF THE ACTUAL SAMPLE, IT IS LIKELY THAT THE ACTUAL SAMPLE WAS EXPOSED TO SOME EXCESSIVE SHOCK DURING THE CIRCULATION AND BECAME DAMAGED. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED LEAKAGE WITH THE INVOLVED CAPIOX RX25 DEVICE. THE LEAKAGE COULD NOT BE FOUND DURING PRIMING. AT THE START OF CPB, THE PERFUSIONIST FOUND THE LEAKAGE AT THE JOINT OF SAMPLING LINE WITH THE RESERVOIR PORT (VENOUS INLET), HE CUT OFF THE SAMPLING LINE AND CLOSED THE FRACTURE. THE PROCEDURE OUTCOME AND PATIENT IMPACT WAS REPORTED TO BE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125232 CAPIOX RX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 180831C 04987350769572

    Patients

    Seq Age Sex Outcome Treatment
    1