BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE FX25RWC W/ RES

    MDR report key: 17458131 · Received August 4, 2023

    Report

    Report Number
    1124841-2023-00185
    Event Type
    Malfunction
    Date Received
    August 4, 2023
    Date of Event
    July 14, 2023
    Report Date
    September 14, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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: 918- PROBE. 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.

    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 AUGUST 04, 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 AND DEVICE EVALUATION). H3 (DEVICE EVALUATED BY MANUFACTURER). H4 (DEVICE MANUFACTURE DATE). 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, IT WAS CONFIRMED THAT THE VENOUS TEMP PROBE WAS BROKEN 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.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SET UP, THE THERMISTOR PROBE ON THE VENOUS INLET PORT WAS BROKEN. NO PATIENT INVOLVEMENT. THE PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    BROKEN THERMOSTAT PROBE ON THE VENOUS INLET PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890501 STERILE FX25RWC W/ RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3CX*FX25RWC 3E24 00699753450837

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown