BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 25253187 · Received May 22, 2026

    Report

    Report Number
    8010762-2026-0000252
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 22, 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
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT ONE HL20 PUMP DISPLAYED THE ERROR MESSAGE ¿RUNAWAY¿. THE EVENT OCCURRED DURING A ROUTINE CHECK. NO HARM TO ANY PERSON HAS BEEN REPORTED. ACCORDING TO THE HL20 SERVICE MANUAL THE ERROR "RUNAWAY" INDICATES THAT THE PUMP HEAD SPEED IS EXCEEDING THE AMOUNT SET AT THE PUMP ROTARY KNOB BY MORE THAN 10%. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2026-05-08. THE FAILURE COULD BE REPRODUCED. ALL CONNECTIONS WERE RESET AND THE CARBON BRUSHES WERE CLEANED. NO PARTS WERE REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. A SIMILAR FAILURE WAS ALREADY ASSESSED BY THE GETINGE LIFE CYCLE ENGINEERING ON 2024-04-15. THE MOST PROBABLE ROOT CAUSE WAS DETERMINED AS USE RELATED CONTAMINATED OF THE MOTOR TACHO BY CARBON ABRASION. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2026-05-22 FOR THE PERIOD OF 2019-03-20 TO 2026-05-06. 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 2019-03-20. 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 RESULTS THE REPORTED FAILURE "ERROR MESSAGE RUNAWAY" 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. THIS EVENT OCCURRED ON THE INDIAN MARKET ON A SIGNIFICANTLY SIMILAR DEVICE TO "VARIO TWIN, HL 20 4-PUMPS", WHICH IS SOLD IN THE US UNDER PREMARKET SUBMISSION NUMBER K943803 FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. FOR D4 UNIQUE IDENTIFIER (UDI)#, PRIMARY DI NUMBER HAS BEEN USED FOR VARIO TWIN, HL 20 4-PUMPS WITH CATALOG NUMBER 701043262, WHICH IS SOLD IN THE US. PROVIDED D4 SERIAL NUMBER AND H4 DEVICE MANUFACTURER DATE CORRESPOND TO DEVICE INVOLVED IN THE EVENT, NOT AVAILABLE IN US.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE HL20 PUMP DISPLAYED THE ERROR MESSAGE ¿RUNAWAY¿. THE EVENT OCCURRED DURING A ROUTINE CHECK. NO HARM TO ANY PERSON HAS BEEN REPORTED. ACCORDING TO THE HL20 SERVICE MANUAL THE ERROR "RUNAWAY" INDICATES THAT THE PUMP HEAD SPEED IS EXCEEDING THE AMOUNT SET AT THE PUMP ROTARY KNOB BY MORE THAN 10%. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375594 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH HL 20 04037691773032

    Patients

    Seq Age Sex Outcome Treatment
    1