BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX RX25 OXYGENATOR WEST

    MDR report key: 13052754 · Received December 21, 2021

    Report

    Report Number
    1124841-2021-00281
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    December 6, 2021
    Report Date
    February 11, 2022
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    UDI-DI
    00699753450110
    PMA / PMN Number
    K153213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS ¿ AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS IN THE INITIAL REPORT SUBMITTED TO THE FDA ON DECEMBER 21, 2021. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: D4 (ADDITIONAL DEVICE INFORMATION - ADDED EXPIRATION DATE AND LOT NUMBER). G3 (DATE RECEIVED BY MANUFACTURER). G6 (INDICATION THAT THIS IS A FOLLOW-UP REPORT). H2 (FOLLOW-UP DUE TO ADDITIONAL INFORMATION). H4 (DEVICE MANUFACTURE DATE). H6 (IDENTIFICATION OF EVALUATION CODES 3331, 4114, 11, 3259, 4307). TYPE OF INVESTIGATION: #1: 11 - TESTING OF DEVICE FROM SAME LOT/BATCH RETAINED BY MANUFACTURER TYPE OF INVESTIGATION #2: 3331 - ANALYSIS OF PRODUCTION RECORDS. TYPE OF INVESTIGATION #3: 4114 - DEVICE NOT RETURNED. INVESTIGATION FINDINGS: 3259 - IMPROPER PHYSICAL STRUCTURE. INVESTIGATION CONCLUSIONS: 4307 - CAUSE TRACED TO COMPONENT FAILURE. THE AFFECTED SAMPLE WAS NOT RETURNED; HOWEVER, A PICTURE WAS PROVIDED THAT SHOWED THE ARTERIAL THERMISTOR BEING BROKEN OFF. A REPRESENTATIVE RETENTION SAMPLE WAS REVIEWED AND FOUND TO HAVE NO DAMAGE TO THE OXYGENATOR, SPECIFICALLY IN THE AREA OF THE ARTERIAL THERMISTOR. ALL CAPIOX UNITS ARE 100% VISUALLY INSPECTED AT SEVERAL POINTS IN THE PRODUCTION PROCESS. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Additional Manufacturer Narrative · 0

    TERUMO HAS NOT RECEIVED THE DEVICE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND WHEN MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY, DURING SETUP, THEY NOTICED A BROKEN CONNECTOR COMING OFF THE OXYGENATOR. NO PATIENT INVOLVEMENT; PRODUCT WAS CHANGED OUT; PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1950607 CAPIOX RX25 OXYGENATOR WEST BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3CX*RX25RW ZG14 00699753450110

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown