BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE FX25RWC W/ RES

    MDR report key: 16682592 · Received April 5, 2023

    Report

    Report Number
    1124841-2023-00080
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    February 6, 2023
    Report Date
    May 11, 2023
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    UDI-DI
    00699753450837
    PMA / PMN Number
    K151791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 APRIL 5, 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 DAMAGE TO THE VENOUS INLET PORTS. NO OTHER DAMAGE WAS NOTED. 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: 2292 - DEFECTIVE COMPONENT. INVESTIGATION FINDINGS: 3233 - RESULTS PENDING COMPLETION OF INVESTIGATION. INVESTIGATION CONCLUSIONS: 11 - CONCLUSION NOT YET AVAILABLE.

    Description of Event or Problem · 0

    DAMAGED OXYGENATORS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING OUT OF BOX, THE O-PORT IN THE OXYGENATORS WERE DAMAGED. AS PER THE SUBSIDIARY, THE ISSUE WAS DETECTED DURING ASSEMBLY IN THE TERUMO UK CLEAN ROOM. THE ISSUE WAS FOUND THE QC SUPERVISOR WHEN INSPECTING THE OXY PRIOR TO USE IN A PACK. *NO PATIENT INVOLVEMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2253731 STERILE FX25RWC W/ RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3CX*FX25RWC 2L05 00699753450837

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown