BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 23041747 · Received September 12, 2025

    Report

    Report Number
    1828100-2025-00228
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    June 17, 2025
    Report Date
    May 29, 2026
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    UDI-DI
    00886799000687
    PMA / PMN Number
    K172220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED BLOCKS: D4, D9, AND H4. THIS DEVICE IS INTENDED FOR EXPORT AND ONLY SHIPPED TO JAPAN AND THEREFORE DOES NOT CONTAIN A UDI LABEL, BUT THE APPLICABLE UDI INFORMATION ASSOCIATED WITH THE DEVICE IS (B)(4).

    Additional Manufacturer Narrative · 0

    UPDATED BLOCKS: D4, H4 & H6. THE REPORTED COMPLAINT WAS CONFIRMED VIA A PHOTOGRAPH PROVIDED. MULTIPLE DILIGENCE ATTEMPTS FOR PART RETURN WERE UNSUCCESSFUL AND THEREFORE, NO EVALUATION OR TESTING WAS PERFORMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    UPDATED BLOCKS: H3 & H6. THE SERVICE REPAIR TECHNICIAN (SRT) DUPLICATED THE REPORTED COMPLAINT. HOWEVER, PER THE SRT, THIS IS NORMAL SYSTEM BEHAVIOR. THE FLOW VALUES ARE OBTAINED FROM THE FLOW SENSOR IN LITERS PER MINUTE (L/MIN) WHEREAS MILLILITERS PER KILOGRAM PER MINUTE (ML/KG/MIN) AND LITERS PER MINUTE PER SQUARE METER (L/MIN/M2) ARE OBTAINED USING BODY SURFACE FORMULA. BOTH THE ML/KG/MIN AND L/MIN/M2 DEPEND ON THE FLOW SENSOR VALUE TO CALCULATE. WHEN THE FLOW SENSOR WAS DISCONNECTED FROM THE CIRCUIT, THIS CAUSED THE DISPLAY TO SHOW DASHES (---). THE LAST CALCULATED VALUE FOR ML/KG/MIN OR L/MIN/M2 WILL REMAIN DISPLAYED UNTIL THE FLOW SENSOR IS RECONNECTED. THE UNIT OPERATED TO THE MANUFACTURER'S SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    D4 - THE UDI AND RELATED INFORMATION IS NOT PROVIDED AS THE SERIAL NUMBER IS UNKNOWN AT THIS TIME. DILIGENCE ATTEMPTS ARE BEING PERFORMED TO RETRIEVE THE SERIAL NUMBER. H4 - THE MANUFACTURE DATE IS NOT PROVIDED AS THE SERIAL NUMBER IS UNKNOWN AT THIS TIME. DILIGENCE ATTEMPTS ARE BEING PERFORMED TO RETRIEVE THE SERIAL NUMBER.

    Description of Event or Problem · 0

    AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE USER REPORTED THAT THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED DASHES FOR THE LITERS PER MINUTE (L/MIN) FLOW RATE, INDICATING ZERO FLOW. HOWEVER, WHEN SWITCHING TO ALTERNATIVE FLOW RATE DISPLAY UNITS, LITERS PER MINUTE PER METER SQUARED (L/MIN/M2) OR MILLILITERS PER KILOGRAM PER MINUTE (ML/KG/MIN), FLOW VALUES CONTINUED TO BE SHOWN. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43092 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 802018 00886799000687

    Patients

    Seq Age Sex Outcome Treatment
    1