BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE FX25REC W/RES

    MDR report key: 15220695 · Received August 12, 2022

    Report

    Report Number
    1124841-2022-00140
    Event Type
    Malfunction
    Date Received
    August 12, 2022
    Date of Event
    July 8, 2022
    Report Date
    December 9, 2022
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    UDI-DI
    00699753450820
    PMA / PMN Number
    K151791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. (B)(4).

    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 12, 2022. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: A2 (AGE AT TIME OF THE EVENT - ADDED NEW INFORMATION) A3 (GENDER - ADDED NEW INFORMATION) A4 (PATIENT WEIGHT - ADDED NEW INFORMATION) B5 (DESCRIBE EVENT OR PROBLEM - ADDED NEW INFORMATION) B6 (RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES - 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: 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, 213, 67). TYPE OF INVESTIGATION #1: 10 - TESTING OF ACTUAL/SUSPECTED DEVICE. TYPE OF INVESTIGATION #2: 3331 - ANALYSIS OF PRODUCTION RECORDS. INVESTIGATION FINDINGS: 213 - NO DEVICE PROBLEM FOUND. INVESTIGATION CONCLUSIONS: 67 - NO PROBLEM DETECTED. THE RETURNED SAMPLE WAS INSPECTED UPON RECEIPT AND NO ANOMALIES WERE NOTED. THE RETURNED SAMPLE WAS SET UP TO TEST THE PPRV. THE DEVICE WAS FOUND TO FUNCTION AS INTENDED. DUE TO HIGH BLOOD VOLUME IN RESERVOIR, THERE WOULD BE LITTLE ROOM FOR AIR TO GO; THEREFORE, LARGE AMOUNTS OF AIR ESCAPED THROUGH PPRV, ACTIVATING THE PPRV. 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: H3 (DEVICE EVALUATION ANTICIPATED BY MANUFACTURER - A THIRD 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.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, AN EXCESSIVE OVERPRESSURE IN THE RESERVOIR WAS NOTED. IT IS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY. AS PER SUBSIDIARY, AT THE AKH VIENNA,"THERE WAS A PROBLEM WITH AN FX25 OXYGENATOR WITH EXCESSIVE OVERPRESSURE IN THE RESERVOIR. THE RESERVOIR WAS FULL, AND THE SUCTION DEVICES WERE AT MAXIMUM BECAUSE THEY HAD TO GO TO THE MACHINE IN AN EMERGENCY. IN THE END, THE PERFUSIONIST HAD TO EXCHANGE THE OXY DURING THE SURGERY AND WAS THEN ABLE TO COMPLETE THE SURGERY WITHOUT ANY FURTHER PROBLEMS. NO HEALTH CONSEQUENCES OR IMPACT. PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    NEW INFORMATION RECEIVED THAT, THE PROCEDURE WAS FOR AORTIC ARCH ANEURYSM, WHERE IN THE FIRST SURGERY WAS PERFORMED TO REPLACE THE AORTIC VALVE. ON THE RE-SURGERY, ANOTHER AORTIC VALVE WAS REPLACED, IN WHICH DURING THIS PROCEDURE, THE INCIDENT OCCURRED. TO MITIGATE THE PROBLEM, THE COMPLETE HLM WAS EXCHANGED INCLUDING THE OXYGENATOR; WHICH WAS REPLACED WITH AN IDENTICAL OXYGENATOR. IT DID NOT SIGNIFICANTLY DELAY THE CONTINUATION OF THE PROCEDURE AND PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817001 STERILE FX25REC W/RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3CX*FX25REC ZG21 00699753450820

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male