BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17019860 · Received May 30, 2023

    Report

    Report Number
    1124841-2023-00133
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    May 8, 2023
    Report Date
    June 29, 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 30, 2023. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: B5 (DESCRIBE EVENT OR PROBLEM - ADDED NEW INFORMATION); G3 (DATE RECEIVED BY MANUFACTURER) ; G6 (INDICATION THAT THIS IS A FOLLOW-UP REPORT) ; H2 (FOLLOW-UP DUE TO ADDITIONAL INFORMATION) ; 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.

    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: B5 (DESCRIBE EVENT OR PROBLEM - ADDED CORRECTION); 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 CORRECTION AND ADDITIONAL INFORMATION) ; H4 (DEVICE MANUFACTURE DATE); H6 (IDENTIFICATION OF EVALUATION CODES 3331, 4114, 3221, 4315). 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: 3221 - NO FINDINGS AVAILABLE. INVESTIGATION CONCLUSIONS: 4315 - CAUSE NOT ESTABLISHED. THE AFFECTED SAMPLES WERE NOT RETURNED FOR EVALUATION. THE SUPPLIER WAS PREVIOUSLY NOTIFIED OF THIS ISSUE AND NOTED THAT PREVIOUS SAMPLES APPEARED TO BE SQUEEZED BY OUTER FORCE. THEY 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 AND 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 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: 2645 - NO PATIENT INVOLVEMENT. HEALTH EFFECT - CLINICAL CODE: 4582 - NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. 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 A FEW MINUTES DELAY, AND NOT HARMFUL.

    Description of Event or Problem · 0

    THE INITIAL STATEMENT ON THE EVENT DETAILS HAS BEEN CORRECTED INDICATING THAT THE PRODUCT WAS CHANGED OUT.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE CONNECTOR IS DAMAGED/CRACKED. IT IS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE. 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. ADDITIONALLY, ONE WAS CHANGED OUT, AND NOT THE COMPLETE PACK. NO PATIENT INVOLVEMENT. THE PRODUCT WAS NOT CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618716 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