BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NS FX25REC W/RES

    MDR report key: 11757400 · Received April 30, 2021

    Report

    Report Number
    1124841-2021-00096
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 13, 2021
    Report Date
    June 10, 2021
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    PMA / PMN Number
    K151791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 APRIL 30, 2021. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: D4 (ADDITIONAL DEVICE INFORMATION - ADDED EXPIRATION DATE) G3 (DATE RECEIVED BY MANUFACTURER) G6 (INDICATION THAT THIS IS A FOLLOW-UP REPORT) H2 (FOLLOW-UP DUE TO ADDITIONAL INFORMATION AND DEVICE EVALUATION) H3 (DEVICE EVALUATED BY MANUFACTURER) H4 (DEVICE MANUFACTURE DATE) H6 (IDENTIFICATION OF EVALUATION CODES 10, 11, 3331, 3259, 4307) TYPE OF INVESTIGATION #1: 10 - TESTING OF ACTUAL/SUSPECTED DEVICE TYPE OF INVESTIGATION #2: 11 - TESTING OF DEVICE FROM SAME LOT/BATCH RETAINED BY MANUFACTURER TYPE OF INVESTIGATION #3: 3331 - ANALYSIS OF PRODUCTION RECORDS INVESTIGATION FINDINGS: 3259 - IMPROPER PHYSICAL STRUCTURE INVESTIGATION CONCLUSIONS: 4307 - CAUSE TRACED TO COMPONENT FAILURE THE AFFECTED SAMPLE WAS INSPECTED UPON RECEIPT TO CONFIRM A BROKEN VENOUS THERMISTOR. REPRESENTATIVE RETENTION SAMPLES OF THE SAME LOT NUMBER WERE REVIEWED FOR DAMAGE TO THE VENOUS INLET ON THE RESERVOIR WITH NO DAMAGE OBSERVED ON THE SAMPLE. A REVIEW OF NCRS SHOWED NCR 21-0157 FOR BROKEN VENOUS THERMISTORS FOUND IN PRODUCTION. APPROPRIATE FIXTURES IN THE PRODUCTION PROCESS WERE MODIFIED TO PROVIDE MORE CLEARANCE IN AN EFFORT TO ELIMINATE THE POSSIBILITY OF CONTACT BETWEEN THE VENOUS PORT THERMISTOR AND THE FIXTURES. BEFORE THE FIXTURES WERE MODIFIED, HARD CONTACT WAS POSSIBLE IF THE VENOUS PORT WAS NOT ROTATED TO A SPECIFIC POSITION PRIOR TO PLACING THE LID ASSEMBLY INTO THE RESERVOIR ASSEMBLY FIXTURE. ALSO A QUALITY BULLETIN WAS OPENED TO RAISE AWARENESS AND PROVIDED TRAINING FOR ALL PRODUCTION OPERATORS THAT HANDLE THERMISTORS AND THE SUBASSEMBLIES INTO WHICH THEY ARE BUILT. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE DEVICE FOR EVALUATION; HOWEVER, 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 · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING OUT OF BOX, THE VENOUS TEMPERATURE SENSOR WAS FOUND TO BE BROKEN OFF. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651026 NS FX25REC W/RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3ZZ*FX25RECA YM05

    Patients

    Seq Age Sex Outcome Treatment
    1