BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3/8" X 3/8"LL XCT 1400CS

    MDR report key: 17437896 · Received August 1, 2023

    Report

    Report Number
    1124841-2023-00181
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    June 30, 2023
    Report Date
    September 8, 2023
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    KRI
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. FOR THIS REASON, TERUMO REFERENCES EVALUATION CONCLUSION CODE 11. H6: COMPONENT CODE: 4733 - CONNECTOR/COUPLER. HEALTH EFFECT - IMPACT CODE: 4648 - INSUFFICIENT INFORMATION. HEATLH EFFECT - CLINICAL CODE: 4580 - INSUFFICIENT INFORMATION. MEDICAL DEVICE PROBLEM CODE: 1135 - CRACK. INVESTIGATION FINDINGS: 3233 - RESULTS PENDING COMPLETION OF INVESTIGATION. INVESTIGATION CONCLUSIONS: 11 - CONCLUSION NOT YET AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: D4 (ADDITIONAL DEVICE INFORMATION - ADDED EXP 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 RETURNED SAMPLE WAS VISUALLY INSPECTED UPON RECEIPT WITH NO CRACKS NOTED UNDER NORMAL VISUAL INSPECTION. MAGNIFICATION WAS USED TO INSPECT THE UNIT AND A CRACK WAS NOTED TO BE WITHIN THE LUER PORT. THE SUPPLIER WAS PREVIOUSLY NOTIFIED OF THIS ISSUE. THEY NOTED THAT PREVIOUS SAMPLES APPEARED TO BE SQUEEZED BY OUTER FORCE. THE SUPPLIER REVIEWED THE FOLLOWING ITEMS: THE INSPECTION RECORD WITH ITS MOLDING BATCH WITH RAW MATERIAL, THE INJECTION MACHINE LOG AND ANNEALING OVEN, INJECTION PARAMETER SETTINGS AND ANNEALED PARAMETER SETTINGS, NO ANOMALIES WERE FOUND WITHIN ANY OF THE RECORDS. RETAIN SAMPLES WERE OBTAINED AND NO CRACKING WAS FOUND. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    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 AUGUST 1, 2023. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: D9 (DEVICE AVAILABILITY - ADDED DATE RETURNED TO MANUFACTURER). G3 (DATE RECEIVED BY MANUFACTURER). G6 (INDICATION THAT THIS IS A FOLLOW-UP REPORT). H2 (FOLLOW-UP DUE TO ADDITIONAL INFORMATION). H3 (DEVICE EVALUATION ANTICIPATED BY MANUFACTURER - A SECOND FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION AND/OR SUBMISSION OF NEW INFORMATION, THUS TCVS REFERENCES CONCLUSIONS CODE 11.) ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR A CRACKED CONNECTOR. IT IS UNKNOWN WHEN THIS EVENT OCCURRED, WHETHER THERE WAS A DELAY IN THE PROCEDURE, WHETHER THE PRODUCT WAS CHANGED OUT, OR IF THERE WAS ANY EFFECT ON THE PATIENT RESULTS OF THE SURGERY. DUE TO THE UNKNOWN INFORMATION FOR THIS EVENT, IT IS BEING REPORTED. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY. AS PER THE SUBSIDIARY, A LEAKAGE OCCURRED AT THE CONNECTOR WHERE THEY MEASURED THE PRE-OXYGENATOR PRESSURE BETWEEN CP AND OXYGENATOR.

    Description of Event or Problem · 0

    CRACKED CONNECTOR.

    Description of Event or Problem · 0

    CRACKED CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344745 3/8" X 3/8"LL XCT 1400CS N/A KRI TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 0007-04427X 2D14

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown