BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 16511977 · Received March 9, 2023

    Report

    Report Number
    1828100-2023-00075
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 15, 2023
    Report Date
    April 10, 2023
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    UDI-DI
    00886799000748
    PMA / PMN Number
    K172220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT WAS 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

    THE FIELD SERVICE REPRESENTATIVE (FSR) COULD NOT VERIFY THE REPORTED COMPLAINT. THE PST DID NOT OBSERVE ANY DAMAGE TO EITHER OF THE TWO TEMPERATURE MODULES OR CONNECTIONS WHEN INSPECTED. THE DATA LOGS WERE REVIEWED BY A TECHNICAL SUPPORT SPECIALIST, AND IT WAS VERIFIED THAT ONE MODULE ALARMED WHEN THE TEMPERATURE WENT OVER THE SET THRESHOLD. BOTH MODULES PASSED RELEASE TESTING. THE UNIT OPERATED TO THE MANUFACTURER'S SPECIFICATIONS. THE OTHER PRESSURE MODULE THAT WAS TESTED WAS PART NUMBER: 802114, SERIAL NUMBER: (B)(4). UDI:(B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE REPORTED ISSUE OCCURRED DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE. PER CLINICAL REVIEW: ON (B)(6) 2023, THE TEAM EXPERIENCED A PROBLEM WITH THEIR HEART LUNG MACHINE (HLM) DURING SET-UP FOR A CASE, WHEREBY ALL THE TEMPERATURES (CARDIOPLEGIA, ARTERIAL, VENOUS) STARTED TO ALARM FOR NO APPARENT REASON. THE MANUFACTURER'S CLINICAL REVIEW SPECIALIST COMMUNICATED WITH THE CLINICIAN, AND HE CONFIRMED THAT THE INCIDENT WAS DISCOVERED DURING SET-UP (NOT DURING CARDIOPULMONARY BYPASS) AND THAT THE ENTIRE HLM WAS CHANGED OUT BEFORE THE PATIENT WAS BROUGHT INTO THE ROOM, WITH NO DELAY OR BLOOD LOSS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THERE WERE MULTIPLE TEMPERATURE ALARMS DESPITE ALL TEMPERATURES BEING WITHIN PARAMETERS. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO BLOOD LOSS, NOR REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716701 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 802114 00886799000748

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown