BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 20157116 · Received September 6, 2024

    Report

    Report Number
    1828100-2024-00248
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 13, 2024
    Report Date
    January 13, 2025
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    UDI-DI
    00886799001387
    PMA / PMN Number
    K172220
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED BLOCKS: H6. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. 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

    PER THE USER FACILITY, THERE WERE NO HIGH PRESSURE OR RETROGRADE FLOW ALARMS ON THE PUMP, AND IT WAS POSSIBLY A HIGH-PRESSURE EXCURSION (HPE) EVENT WITH THE PATIENT.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) COULD NOT DUPLICATE THE REPORTED COMPLAINT. THE CENTRIFUGAL AND FLOW SYSTEMS WERE RELEASE TESTED, AND THE ISSUE IS BELIEVED TO HAVE BEEN DUE TO A HIGH-PRESSURE EXCURSION (HPE) EVENT WITH THE PATIENT. THE UNIT OPERATED TO THE MANUFACTURER'S SPECIFICATIONS.

    Description of Event or Problem · 0

    PER CLINICAL REVIEW: ON (B)(6) 2024, THE TEAM AT THE USER FACILITY EXPERIENCED A PROBLEM WITH THEIR CENTRIFUGAL CONTROL UNIT DURING AN ADULT CARDIOPULMONARY BYPASS PROCEDURE WHEREBY THE UNIT COULD NOT PRODUCE FORWARD FLOW DESPITE SHOWING 3000 REVOLUTIONS PER MINUTE (RPMS) ON THE MONITOR. NO HIGH PRESSURE OR RETROGRADE FLOW ALARMS WENT OFF ON THE PUMP, SO THE TEAM WAS NOT SURE WHAT HAPPENED. IT WAS THOUGHT TO HAVE POSSIBLY BEEN A HIGH PRESSURE EXCURSION EVENT WITH THE PATIENT. THE TEAM OPTED TO COME OFF BYPASS AND AFTER 10 MINUTES, THEY TRIED AGAIN ON THE SAME CIRCUIT, AND IT WORKED FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE CENTRIFUGAL CONTROL UNIT (CCU) DID NOT PRODUCE FORWARD FLOW DESPITE SHOWING 3,000 REVOLUTIONS PER MINUTE (RPMS) ON THE MONITOR. AS MITIGATION, THE TEAM CAME OFF BYPASS AND THEN WENT BACK ON WITH THE SAME CIRCUIT AFTER 10 MINUTES AND IT WORKED FINE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A 10-MINUTE DELAY. THERE WAS NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2041595 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 816572 00886799001387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention