BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX

    MDR report key: 20134966 · Received September 4, 2024

    Report

    Report Number
    9681834-2024-00151
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 8, 2024
    Report Date
    September 4, 2024
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K982467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3A: SEX: REQUESTED, NOT PROVIDED. A3B: GENDER: N/A. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D4: UDI: N/A AS THIS PRODUCT CODE IS BULK PRODUCT. D4: LOT NUMBER: 1231205-010. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: QUALITY ASSURANCE DEPARTMENT. THE ACTUAL SAMPLE WAS DISCARDED BY THE INVOLVED FACILITY. ON-SITE INVESTIGATION RESULTS: AN AIR LEAK WAS OBSERVED NEAR THE BLOOD INLET PORT. VISUAL INSPECTION OF THE ACTUAL SAMPLE UPON ARRIVAL AT THE FACTORY: NO BREAKAGE OR SIMILAR ANOMALIES WERE FOUND IN THE APPEARANCE OF THE ACTUAL SAMPLE. LEAK TEST OF THE ACTUAL SAMPLE: TO CONDUCT THE LEAK TEST, THE ACTUAL SAMPLE WAS FILLED WITH COLORED SALINE SOLUTION, THE BLOOD OUTLET PORT WAS SEALED, AND PRESSURE UP TO 100KPA WAS APPLIED FROM THE BLOOD INLET PORT SIDE. A LEAK FROM THE CONNECTION WITH THE TUBE WAS CONFIRMED. MAGNIFYING INSPECTION OF THE BLOOD INLET PORT. THE TUBE WAS DETACHED, AND A MAGNIFYING INSPECTION OF THE BLOOD INLET PORT WAS CONDUCTED UNDER A MICROSCOPE. NO BREAKAGE OR SIMILAR ANOMALIES WERE OBSERVED. LEAK TEST OF THE ACTUAL SAMPLE USING A FACTORY-RETAINED TUBE: A FACTORY-RETAINED 1/4-INCH TUBE WAS CONNECTED TO THE BLOOD INLET PORT OF THE ACTUAL SAMPLE AND A LEAK TEST WAS PERFORMED FOLLOWING THE SAME PROCEDURE DESCRIBED IN THE INVESTIGATION RESULT 3. NO LEAK WAS CONFIRMED DURING THIS TEST. THE MANUFACTURING RECORD AND THE INCOMING INSPECTION RECORD OF THE ACTUAL SAMPLE, NO ANOMALY WAS FOUND. NO SIMILAR COMPLAINTS HAVE BEEN FILED. BASED ON THE INVESTIGATION RESULTS, IT WAS CONFIRMED THAT THE LEAK ORIGINATED FROM THE CONNECTION BETWEEN THE BLOOD INLET PORT AND THE INVOLVED TUBE. SINCE NO ANOMALIES WERE FOUND IN THE BLOOD INLET PORT OF THE ACTUAL SAMPLE AND NO LEAK OCCURRED DURING THE LEAK TEST WITH THE FACTORY-RETAINED TUBE, IT WAS INFERRED THAT A GAP EXISTED BETWEEN THE BLOOD INLET PORT AND THE INVOLVED TUBE DURING THE EVENT, RESULTING IN THE LEAK. BASED ON OUR PREVIOUS EXPERIENCES, IT WAS INFERRED THAT THE GAP WAS CAUSED POTENTIALLY BY THE ATTACHMENT OF A TIE BAND AND LED TO LEAKAGE PATH. HOWEVER, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. 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 PATIENT UNDERWENT A TRIPLE CORONARY ARTERY BYPASS GRAFTING UNDER CEC. DURING THE OPERATION, BLOOD LEAKED FROM THE CARDIOPLEGIA MODULE. THE PATIENT WAS AT RISK OF INFECTION. THERE WAS A RISK OF STOPPING THE PROCEDURE IF THERE WAS BLOOD IN THE CARDIOPLEGIA FLUID. THERE WERE NO CONSEQUENCES FOR THE PATIENT POSTOPERATIVELY. THE SAMPLE ARRIVED AT HMT AND WAS TESTED. A LEAK WAS DETECTED. THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967151 CAPIOX OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA 1ZZ*CP50 230510

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown