BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOHELP

    MDR report key: 12540683 · Received September 28, 2021

    Report

    Report Number
    8010762-2021-00527
    Event Type
    Death
    Date Received
    September 28, 2021
    Report Date
    August 3, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Adverse Event
    Yes
    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

    IT WAS REPORTED THAT THE DISPLAY WENT BLACK DURING SET UP OF THE DEVICE. THE CUSTOMER REPORTED THAT THE PATIENT EXPIRED DUE TO NOT BEING ABLE TO PUT IN SUPPORT. THEY DID NOT HAD A SPARE DEVICE. THE SENSOR PANEL, CARDIOHELP USER INTERFACE AND THE HMI BOARD WAS RETURNED TO MANUFACTURER FOR TECHNICAL INVESTIGATION. A TECHNICAL INVESTIGATION WAS PERFORMED BY GETINGE LIFE-CYCLE-ENGINEERING ON (B)(6) 2022. AS A RESULT OF THE LOG FILES ANALYSIS AND THE DESCRIBED ERROR, A ROOT CAUSE COULD BE ISOLATED: THE CARDIOHELP EXPERIENCED INTERNAL MALFUNCTIONS WITH THE POWER / VOLTAGE SUPPLY OF THE 24V, 1.8V AND THE 3.3 V. BASED ON THESE RESULTS, A DEEPER ROOT CAUSE ANALYSIS WAS PERFORMED BY GETINGE LIFE-CYCLE-ENGINEERING ON (B)(6) 2022 WITH THE FOLLOWING RESULT: THE MOST PROBABLE ROOT CAUSE IS A DEFECT IN THE HMI BOARD, WHICH CANNOT BE REPRODUCED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿ S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.

    Additional Manufacturer Narrative · 0

    A GETINGE SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON (B)(6) 2021. THE SENSOR PANEL, CARDIOHELP USER INTERFACE HARDWARE KIT AND THE HMI BOARD WERE REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE FST CONFIRMED THAT ALL SERVICES IN THE PAST WERE DONE IN TIME. THE SENSOR PANEL, CARDIOHELP USER INTERFACE AND HMI BOARD WAS SENT TO MANUFACTURER FOR TECHNICAL INVESTIGATION. ACCORDING TO THE LOGFILES ANALYSIS AND THE DESCRIBED FAILURE THE GETINGE LIFE-CYCLE- ENGINEERING CAN NARROW DOWN A ROOT CAUSE ON (B)(6) 2022. THE CARDIOHELP HAD FAILURES WITH THE POWER- /VOLTAGE SUPPLY BETWEEN (B)(6) 2021 AND (B)(6) 2021. A MEDICAL REVIEW WAS PERFORMED BY GETINGE MEDICAL AFFAIRS ON 2022-05-04 WITH FOLLOWING CONCLUSION: BASED ON THE INVESTIGATION RESULTS OF GETINGE LIFE-CYCLE-ENGINEERING AND MEDICAL EVALUATION, IT IS CUSTOMARY, AND, OFTENTIMES, REQUIRED BY LOCAL HEALTH REGULATORY AGENCIES THAT MEDICAL DEVICES USED FOR LIFE SUPPORT SHOULD HAVE A BACKUP DEVICE/SYSTEM (OR, SECONDARY SUPPORT SYSTEMS) AVAILABLE IN THE EVENT OF A FULL DEVICE/SYSTEM MALFUNCTION. IN THIS COMPLAINT, THE TIME TO SUPPORT WAS EXTENDED (DELAYED) AND MAY HAVE CONTRIBUTED TO THE OUTCOME OF THE PATIENT (I.E. BARRING EXISTING COMORBIDITIES AND/OR COMPLICATING PATHOLOGIES). IN THOSE CLINICS WHERE EXTRACORPOREAL SUPPORT IS OFFERED, ADDITIONAL SUPPORT VENUES (BACKUPS) ARE CUSTOMARILY AVAILABLE (E.G. HEART-LUNG MACHINES). THE PRODUCT IFU OF THE CARDIOHELP RECOMMENDS THAT BACKUP/REPLACEMENT SYSTEMS ARE ALWAYS AVAILABLE IN THE EVENT OF COMPLETE SYSTEM FAILURE. PRINT-OUTS AND COPIES OF THIS DOCUMENT HAVE TO BE CHECKED FOR VALIDITY AND CORRECTNESS BEFORE USE. IT IS UNKNOWN WHETHER THE CUSTOMER DEPLOYED THE EMERGENCY DRIVE (ER DRIVE) THAT IS AVAILABLE WITH EACH CARDIOHELP SYSTEM. A PICTURE PROVIDED BY THE CUSTOMER SHOWS THAT THE ER DRIVE WAS ACCESSIBLE AS PART OF THE CARDIOHELP SYSTEM AVAILABLE AT THE INSTITUTION. DEPLOYMENT OF THE ER DRIVE MAY HAVE ALLOWED BRIDGING OF THE PATIENT TO A SUITABLE SUPPORT VENUE (E.G. A HEART-LUNG MACHINE) IN THE ABSENCE OF A CARDIOHELP SYSTEM. THE CARDIOHELP IFU INCLUDES STATEMENTS REGARDING USE OF THE EMERGENCY DRIVE (ER DRIVE) IN SIMILAR SITUATIONS. WHILE THE USE OF THE ER DRIVE IS ADDRESSED IN THE PRODUCT IFU, IT IS ALSO COVERED EXTENSIVELY AS PART OF CARDIOHELP PRODUCT TRAINING. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON (B)(6) 2021 FOR THE PERIOD OF (B)(6) 2018 TO (B)(6) 2021. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED DURING THIS TIME, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE PRODUCT IN QUESTION WAS PRODUCED ON (B)(6) 2018. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED ISSUE AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED A FOLLOW-UP EMDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    COMPLAINTNUMBER: (B)(4).

    Description of Event or Problem · 0

    COMPLAINT NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    FURTHER DETAILS ABOUT THE EVENT, PATIENT DATA AND SERVICE OF THE AFFECTED CARDIOHELP UNIT WERE REQUESTED BUT ARE STILL PENDING. A FOLLOW-UP EMDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DISPLAY OF THE CARDIOHELP WENT BACK DURING SET UP. THE UNIT WAS STILL POWERED ON, BUT NOTHING WAS DISPLAYED. THE CUSTOMER DESCRIBED A BUZZING SOUND THAT OCCURRED WHEN THEY ATTEMPTED TO START THE EMERGENCY MODE. THE CARDIOHELP WAS NOT USED ON PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT EXPIRED DUE TO NOT BEING ABLE TO PUT ON SUPPORT. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437399 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death