BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 6573068 · Received May 17, 2017

    Report

    Report Number
    1828100-2017-00239
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Date of Event
    April 25, 2017
    Report Date
    August 8, 2017
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS NOT CONFIRMED. PER DATA LOG ANALYSIS, ON 25-APR-2017, THE GAS SYSTEM WAS SUCCESSFULLY CALIBRATED. FLOW AND FRACTION OF INSPIRED OXYGEN (FIO2) SETTINGS WERE CHANGED SEVERAL TIMES. THERE WAS NO INDICATION OF ANY ISSUES 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 · 1

    (B)(4). THE FSR EVALUATED THE UNIT AND FOUND THE FIO2 WAS WORKING CORRECTLY. THE UNIT OPERATED TO MANUFACTURER'S SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FRACTION OF INSPIRED OXYGEN (FIO2) WAS FLUCTUATING. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) CALIBRATED SUCCESSFULLY AND THE PERFUSIONIST SET THE FIO2 TO ABOUT 0.75 AT THE START OF CPB. A FEW MINUTES INTO CPB, THE FIO2 FLUCTUATED UP / DOWN BETWEEN ABOUT 0.70 - 0.80 IN SMALL INCREMENTS WITHOUT ANY USER ADJUSTMENT. IN A FEW SECONDS THE MEASURED VALUE WOULD RETURN TO THE SET POINT OF ABOUT 0.75. THERE WERE NO GAS PRESSURE ALARMS OR ANY ALARMS, ERRORS, OR STATUS MESSAGES IN REGARDS TO THE EPGS. THE PERFUSIONIST HAD NO ISSUES IN PROVIDING ADEQUATE GAS FLOWS OR FIO2S DURING CPB AND THERE WERE NO ISSUES IN MAINTAINING ADEQUATE OXYGENATION AND / OR CARBON DIOXIDE (CO2) REMOVAL. THE EPGS WAS SUED TO COMPLETE THE PROCEDURE. THIS ADVANCED PERFUSION SYSTEM 1 (APS-1) (WITH INTEGRATED EPGS) WAS REMOVED FROM SERVICE AFTER THE COMPLETION OF THE PROCEDURE. THE LOCAL FIELD SERVICE REPRESENTATIVE (FSR) VISITED THE HOSPITAL AND INSPECTED THE EPGS UNIT AS WELL AS COLLECTED THE APS-1 LOGS. ON INSPECTION OF THE EPGS, THE UNIT CHECKED OUT AND MET ALL SPECIFIED FUNCTIONS. ON REVIEW OF THE LOGS, BY MANUFACTURER TECH SUPPORT, THERE WERE NO OBSERVED ISSUES WITH THE EPGS MODULE ITSELF AND / OR THE OXYGEN SENSOR. IN DISCUSSION WITH TECH SUPPORT, THIS TYPE OF SCENARIO CAN OCCUR IF THE GAS PATH DISTAL TO THE EPGS HAS SOME TYPE OF OBSTRUCTION. OBSTRUCTIONS CAN BE KINKS IN THE GAS LINE TUBING, MOISTURE IN THE TUBING, BLOCKAGES IN THE GAS FILTER, OR OBSTRUCTIONS IN THE VAPORIZER CIRCUIT. I SPOKE TO THE PERFUSIONIST ABOUT CHECKING FOR OBSTRUCTIONS IN THE GAS SUPPLY DISTAL TO THE EPGS AND HE STATED HE WOULD DO THAT AND THIS INCLUDED HAVING THE HOSPITAL BIOMEDICAL ENGINEERING TEAM CHECK OUT THE VAPORIZER. THE CASE WAS COMPLETED SUCCESSFULLY, WITHOUT DELAY AND WITHOUT ASSOCIATED BLOOD LOSS. THERE WAS NO HARM OBSERVED. NOTHING WAS CHANGED OUT DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355398 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP 801188

    Patients

    Seq Age Sex Outcome Treatment
    1