BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NS FX15RWC W/4L RES

    MDR report key: 16544490 · Received March 15, 2023

    Report

    Report Number
    1124841-2023-00068
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 20, 2023
    Report Date
    April 17, 2023
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    PMA / PMN Number
    K151791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 MARCH 15, 2023. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: G6 (INDICATION THAT THIS IS A FOLLOW-UP REPORT). H2 (FOLLOW-UP DUE TO ADDITIONAL INFORMATION AND DEVICE EVALUATION). H6 (IDENTIFICATION OF EVALUATION CODES 10, 3331, 11, 3259, 4307). TYPE OF INVESTIGATION #1: 10 - TESTING OF ACTUAL/SUSPECTED DEVICE. 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: 3259 - IMPROPER PHYSICAL STRUCTURE. INVESTIGATION CONCLUSIONS: 4307 - CAUSE TRACED TO COMPONENT FAILURE. THE AFFECTED SAMPLE WAS INSPECTED UPON RECEIPT AND CONFIRMED THE PURGE LINE, ATTACHED TO THE TOP OF THE OXYGENATOR BUNDLE, WAS SHEARED OFF THE PORT. A REPRESENTATIVE RETENTION SAMPLE WAS INSPECTED FOR DAMAGE WITH NO DAMAGE NOTED ON THE DEVICE. ALL CAPIOX UNITS ARE 100% VISUALLY INSPECTED AT SEVERAL POINTS IN THE PRODUCTION PROCESS. 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. COMPONENT CODE: 4739 - GAS EXCHANGER. HEALTH EFFECT ¿ IMPACT CODE: 2645 - NO PATIENT INVOLVEMENT. HEALTH EFFECT ¿ CLINICAL CODE: 4582 - NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. MEDICAL DEVICE PROBLEM CODE: 1354 - LEAK/SPLASH. INVESTIGATION FINDINGS: 3233 - RESULTS PENDING COMPLETION OF INVESTIGATION. INVESTIGATION CONCLUSIONS: 11 - CONCLUSION NOT YET AVAILABLE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, A LEAK WAS DISCOVERED FROM THE LINE ON THE TOP OF THE OXYGENATOR. NO PATIENT INVOLVEMENT. THE PRODUCT WAS CHANGED OUT . PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037436 NS FX15RWC W/4L RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3ZZ*FX15RW40CA 2K08

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown