BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 23262185 · Received October 9, 2025

    Report

    Report Number
    1828100-2025-00252
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 17, 2025
    Report Date
    December 11, 2025
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    PMA / PMN Number
    K172220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED BLOCK: H6. THE REPORTED COMPLAINT WAS CONFIRMED. PER DATA LOG REVIEW: THERE WAS A FAULTY POWER SUPPLY 1 DURING POWER UP. THE TEAM POWER CYCLED THE UNIT, AND THE ISSUE WAS RESOLVED. NO OTHER ISSUES WERE FOUND IN THE LOG. 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

    THE FIELD SERVICE REPRESENTATIVE (FSR) FOUND THE BATTERIES AT 18 AMP HOURS (AH) THEN DISCHARGE AND SHOW 0 AH. THE FSR REPLACED THE BATTERIES AND COMPLETED RELEASE TESTING. THE UNIT OPERATED TO THE MANUFACTURER'S SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE HEART LUNG MACHINE (HLM) BATTERIES WOULD NOT CHARGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1577722 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 801763

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown