BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 23602819 · Received November 20, 2025

    Report

    Report Number
    8010762-2025-0000510
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    November 14, 2025
    Report Date
    January 8, 2026
    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

    A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT ONSITE FOR INVESTIGATION OF THE DEVICE. THE INVESTIGATION IS ONGOING. AS SOON AS NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A HL20 TPM DISPLAYED THE ERROR MESSAGE BELTSLIP. THE ISSUE WAS OBSERVED DURING ROUTINE CHECKUP. NO HARM TO ANY PERSON WAS REPORTED. ACCORDING TO THE INSTRUCTIONS FOR USE HL 20 VERSION 02 IN CHAPTER 8.1.2 TECHNICAL ALARMS THE ERROR MESSAGE: BELTSLIP DOES NOT LEAD TO A PUMP STOP. THIS ALARM ONLY INDICATES TO THE USER THAT THE PUMP SPEED IS SMALLER THAN 90 PERCENT OF THE MOTOR SPEED. DURING GETINGE FST´S INVESTIGATION AND REPAIR, THE ERROR MESSAGE HEAD WAS ALSO DISPLAYED. ACCORDING TO THE HL20 SERVICE MANUAL THE ERROR HEAD INDICATES THAT THE MOTOR TACHO SHOWS A VALUE BUT THE HEAD TACHO SHOWS 0 (ZERO). SEVERAL BELTSLIP ERRORS RESULT IN A HEAD ERROR. THE AFFECTED HL20 DEVICE WITH SERIAL NUMBER (B)(6) WAS INVESTIGATED BY A GETINGE FIELD SERVICE TECHNICIAN (FST). THE REPORTED FAILURE WAS REPRODUCIBLE. THE OPTICAL TACHO BOARDS WERE REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE REPORTED FAILURE WAS ALREADY INVESTIGATED BY THE GETINGE LIFE CYCLE ENGINEERING IN A SIMILAR CASE. THE MOST PROBABLE ROOT CAUSE WAS DETERMINED AS A DEFECT SENSOR ON THE OPTICAL TACHO BOARD. DUE TO THE AGE OF THE DEVICE AND THE PART OPTICAL TACHO BOARD (ALMOST 10 YEARS OLD) AGE RELATED ASPECTS CAN BE CONSIDERED AS WELL. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-11-18 FOR THE PERIOD OF 2016-02-25 TO 2025-11-15. 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 2016-02-25. 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 MESSAGES: BELTSLIP AND HEAD" COULD BE CONFIRMED. 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.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN INDIA. IT WAS REPORTED THAT A HL20 TPM DISPLAYED THE ERROR MESSAGE BELTSLIP. THE ISSUE WAS OBSERVED DURING ROUTINE CHECKUP. NO HARM TO ANY PERSON WAS REPORTED. ACCORDING TO THE INSTRUCTIONS FOR USE HL 20 VERSION 02 IN CHAPTER 8.1.2 TECHNICAL ALARMS THE ERROR MESSAGE: BELTSLIP DOES NOT LEAD TO A PUMP STOP. THIS ALARM ONLY INDICATES TO THE USER THAT THE PUMP SPEED IS SMALLER THAN 90 PERCENT OF THE MOTOR SPEED. DURING GETINGE FST´S INVESTIGATION AND REPAIR, THE ERROR MESSAGE HEAD WAS ALSO DISPLAYED. ACCORDING TO THE HL20 SERVICE MANUAL THE ERROR HEAD INDICATES THAT THE MOTOR TACHO SHOWS A VALUE BUT THE HEAD TACHO SHOWS 0 (ZERO). THE ERROR MESSAGE: HEAD CAN CAUSE AN UNINTENTIONAL PUMP STOP. THEREFORE, A REPORT IS REQUIRED. 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
    262831 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