BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 17069199 · Received June 6, 2023

    Report

    Report Number
    8010762-2023-00265
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    May 30, 2023
    Report Date
    September 14, 2023
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A GETINGE TECHNICIAN WILL INVESTIGATE THE CARDIOHELP. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE ERROR MESSAGE "SAFETY-S" WAS DISPLAYED ON A HL20 PUMP. THE FAILURE OCCURRED DURING PRIMING. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2023-06-20. THE SAFETY SYSTEM BOARD WAS REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. NO EXACT ROOT CAUSE COULD BE DETERMINED, BECAUSE THE AFFECTED SAFETY SYSTEM BOARD WAS NOT MADE AVAILABLE FOR FURTHER INVESTIGATION. A SIMILAR CASE WAS ALREADY INVESTIGATED BY THE GETINGE LIFE CYCLE ENGINEERING ON 2020-03-09. THE MOST PROBABLE ROOT CAUSE OF THE DESCRIBED ERROR IS A LOOSE CONNECTION IN THE CONDUCTIVE PATH FROM VOLTAGE SUPPLY +12V TO THE VOLTAGE REGULATOR IC5. WITH REFERENCE TO THE HL20 RISK ASSESSMENT (RISK ID: H1.1.1.2.7) THIS EVENT CAN BE ALSO CONTRIBUTED TO: WRONG PUMP SPEED BECAUSE OF: - COMMUNICATION ERROR (E.G. WRONG RATIO BETWEEN MASTER-SLAVE PUMPS DUE TO COMMUNICATION ERROR. THE DEVICE WAS MANUFACTURED ON 2021-10-28. THE DEVICE HISTORY RECORD (DHR) OF THE HL 20 WAS REVIEWED ON 2023-06-02. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY TO HAVE CONTRIBUTED TO THE REPORTED FAILURE. BASED ON THE RESULTS THE REPORTED FAILURE "ERROR MESSAGE SAFETY-S" COULD BE CONFIRMED. THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. 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. 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

    THE INVESTIGATION IS ONGOING. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2023-06-20. THE SAFETY SYSTEM BOARD WAS REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE DEVICE WAS MANUFACTURED ON 2021-10-28. THE DEVICE HISTORY RECORD (DHR) OF THE HL 20 WAS REVIEWED ON 2023-06-02. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY TO HAVE CONTRIBUTED TO THE REPORTED FAILURE. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ERROR MESSAGE "SAFETY-S" WAS DISPLAYED ON A HL20 PUMP DURING PRIMING. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696899 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH HL 20

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown