BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 22628650 · Received July 28, 2025

    Report

    Report Number
    8010762-2025-0000320
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    July 18, 2025
    Report Date
    July 28, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    UDI-DI
    04037691773032
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A HL20 RPM DISPLAYED THE ERROR MESSAGE EEPROM. THE ISSUE WAS OBSERVED DURING ROUTINE CHECKUP. NO HARM TO ANY PERSON WAS REPORTED. ACCORDING TO THE HL20 SERVICE MANUAL THE ERROR MESSAGE EEPROM INDICATED THAT THE INTERNAL INSTRUCTION CODE MEMORY IS FAULTY. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR. THE RPM CONTROL BOARD WAS FOUND TO BE DEFECTIVE AND NEEDS TO BE REPLACED. THE REPORTED ERROR MESSAGE: EEPROM WAS ALREADY INVESTIGATED BY THE GETINGE LIFE CYCLE ENGINEERING WITHIN A SIMILAR COMPLAINT. THE MOST PROBABLE ROOT CAUSE COULD BE DETERMINED TO A DEFECTIVE EEPROM MODULE (IC7) ON THE PUMP CONTROL BOARD. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-07-22 FOR THE PERIOD OF 2016-12-28 TO 2025-07-18. 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 DEVICE WAS MANUFACTURED ON 2016-12-28. IN ADDITION, A REVIEW FOR POTENTIAL FIELD ACTIONS AND CAPAS RELATED TO THE FAILURE AND PRODUCT IN THIS COMPLAINT WAS PERFORMED. THIS COMPLAINT IS NOT IN SCOPE OF ANY ONGOING FIELD ACTIONS AND/OR CAPAS. BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE ERROR MESSAGE: EEPROM 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. NOTE: THIS EVENT OCCURRED ON THE INDIAN MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "BASE UNIT HL 20¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K943803. FOR SECTION D4 ALL AVAILABLE IDENTIFYING INFORMATION IS FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. THEREFORE, NO GUDID INFORMATION EXISTS. FURTHERMORE, UDI INFORMATION (PRIMARY DI NUMBER) PROVIDED IN D4 IS FOR HL 20 WITH CATALOG NUMBER 701043262.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN INDIA. DURING ROUTINE CHECKUP IT WAS OBSERVED THAT A HL20 RPM DISPLAYED THE ERROR MESSAGE EEPROM. NO HARM TO ANY PERSON WAS REPORTED. ACCORDING TO THE HL20 SERVICE MANUAL THE ERROR MESSAGE: EEPROM INDICATED THAT THE INTERNAL INSTRUCTION CODE MEMORY IS FAULTY. THE FAILURE CAN CAUSE AN UNINTENTIONAL PUMP STOP. THEREFORE A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651279 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH HL 20 04037691773032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown