BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NS FX25RWC W/RES

    MDR report key: 17315746 · Received July 13, 2023

    Report

    Report Number
    1124841-2023-00168
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Date of Event
    June 21, 2023
    Report Date
    August 11, 2023
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    PMA / PMN Number
    K151791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 JULY 13, 2023. 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) ; H4 (DEVICE MANUFACTURE DATE); H6 (IDENTIFICATION OF EVALUATION CODES 4114, 3331, 11, 3259, 4210, 4307). TYPE OF INVESTIGATION #1: 4114 - DEVICE NOT RETURNED. TYPE OF INVESTIGATION #2: 3331 - ANALYSIS OF PRODUCTION RECORDS. TYPE OF INVESTIGATION #3: 11 - TESTING OF DEVICE FROM SAME LOT/BATCH RETAINED BY MANUFACTURER. INVESTIGATION FINDINGS #1: 3259- IMPROPER PHYSICAL STRUCTURE. INVESTIGATION FINDINGS #2: 4210- LEAKAGE/SEAL. INVESTIGATION CONCLUSIONS: 4307- CAUSE TRACED TO COMPONENT FAILURE. THE AFFECTED SAMPLE WAS NOT RETURNED FOR EVALUATION; HOWEVER, A VIDEO WAS PROVIDED SHOWING A LEAK AT THE FEMALE L-SHAPED CONNECTOR. A REPRESENTATIVE RETENTION SAMPLE FROM THE SAME LOT NUMBER WAS REVIEWED WITH NO DAMAGE TO THE UNIT NOTED, SPECIFICALLY WITH THE FEMALE L-SHAPED CONNECTOR. THE SAMPLE WAS NOT RETURNED; HOWEVER, THE PROVIDED VIDEO CONFIRMED THE LEAK. DURING THE INVESTIGATIONS OF SIMILAR EVENTS, REPLICATION TESTING FOUND THAT THIS CRACK APPEARS ON THE PART WHEN THE L CONNECTOR IS OVER TIGHTENED ON THE PORT. 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. COMPONENT CODE: (B)(4). 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

    DAMAGED MANIFOLD.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE MANIFOLD WAS DAMAGED. NO PATIENT INVOLVEMENT, PRODUCT WAS CHANGED OUT, PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2260135 NS FX25RWC W/RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3ZZ*FX25RWCA 3A23

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown