BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17011590 · Received May 26, 2023

    Report

    Report Number
    1124841-2023-00121
    Event Type
    Malfunction
    Date Received
    May 26, 2023
    Date of Event
    May 2, 2023
    Report Date
    June 21, 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

    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 MAY 26, 2023. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: H6 (IDENTIFICATION OF EVALUATION CODES 2645, 4582). HEALTH EFFECT - IMPACT CODE: 2645 - NO PATIENT INVOLVEMENT. HEALTH EFFECT - CLINICAL CODE: 4582 - NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. TYPE OF INVESTIGATION #1: 10 - TESTING OF ACTUAL/SUSPECTED DEVICE. TYPE OF INVESTIGATION #2: 3331 - ANALYSIS OF PRODUCTION RECORDS. INVESTIGATION FINDING: 3259 - IMPROPER PHYSICAL STRUCTURE. INVESTIGATION CONCLUSIONS: 4307 - CAUSE TRACED TO COMPONENT FAILURE. UPON EVALUATION OF THE RETURNED SAMPLE, A CRACK ON THE CONNECTOR WAS CONFIRMED. THE SUPPLIER WAS PREVIOUSLY NOTIFIED OF THIS ISSUE. THE SUPPLIER 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. THE OD OF THE LUER WAS MEASURED AND USING THE GO-NO GO, THE ID OF THE LUER WAS MEASURED, ALL RESULTS WERE WITHIN SPECIFICATION. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Additional Manufacturer Narrative · 0

    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. FOR THIS REASON, TERUMO REFERENCES EVALUATION CONCLUSION CODE 11. H6: COMPONENT CODE: 4733 - CONNECTOR / COUPLER. HEALTH EFFECT - IMPACT CODE: 4648 - INSUFFICIENT INFORMATION. HEALTH EFFECT - CLINICAL CODE: 4580 - INSUFFICIENT INFORMATION. MEDICAL DEVICE PROBLEM CODE: 1069 - BREAK. INVESTIGATION FINDINGS: 3233 - RESULTS PENDING COMPLETION OF INVESTIGATION. INVESTIGATION CONCLUSIONS: 11 - CONCLUSION NOT YET AVAILABLE.

    Description of Event or Problem · 0

    NEW INFORMATION RECEIVED INDICATES THAT THERE WAS FEW MINUTES DELAY IN THE PROCEDURE AND THAT THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE CONNECTOR WAS DAMAGED. IT IS UNKNOWN WHETHER THERE WAS A DELAY IN THE PROCEDURE AND WHETHER THE SURGERY AS COMPLETED SUCCESSFULLY. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY. THE PRODUCT WAS CHANGED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886192 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