BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLS SET

    MDR report key: 23321045 · Received October 17, 2025

    Report

    Report Number
    8010762-2025-0000456
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Date of Event
    October 10, 2025
    Report Date
    December 5, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    UDI-DI
    04058863005744
    PMA / PMN Number
    K112360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE POLISH MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "HLS SET¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K112360. 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 HLS SET WITH CATALOG NUMBER 701069073.

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN POLAND. IT WAS REPORTED THAT THE VENOUS PRESSURE SENSOR WAS NOTICED AS DAMAGED IN THE HLS SET. THE DAMAGE WAS DETECTED AFTER MOUNTING THE HLS SET ON THE CARDIHELP-I DEVICE FOR PRIMING AND THE PVEN VALUE COULD NOT BE RESET. THE SET WAS NOT USED FOR TREATMENT. NO PATIENT WAS INVOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS A PRESSURE READING ISSUES CAN LEAD TO A PUMP STOP IF THE INTERVENTION WAS SET BY THE USER A REPORT IS REQUIRED. THE AFFECTED PRODUCT WAS INVESTIGATED IN THE GETINGE LABORATORY ON 2025-11-26 WITH THE FOLLOWING CONCLUSION: THE REPORTED FAILURE COULD BE CONFIRMED DURING THE INVESTIGATION. A MALFUNCTION WITHIN THE SENSOR HAS BEEN DETECTED. THE PROBABLE ROOT CAUSE COULD BE DETERMINED AS A FAULTY BOND CONNECTIONS ON THE CONDUCTOR TRACKS. BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE COULD BE CONFIRMED. NO DEVICE HISTORY REVIEW WAS PERFORMED, AS IT WAS CONFIRMED IN THE GETINGE LABORATORY THAT THE BOND CONNECTION WAS FAULTY. THE REVIEW OF SCRAP, REWORK, ENHANCEMENTS AND DESIGN CHANGES WERE REVIEWED AND NO ABNORMALITIES IN REGARDS TO THE REPORTED FAILURE WERE FOUND. 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. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED FOR THE REVIEWED TIME PERIOD: IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARDS TO THE REPORTED PRODUCT AND FAILURE. THE COMPLAINT INFORMATION WAS TRANSFERRED TO THE INTERNAL NONCONFORMITY PROCESS (NC) AND FURTHER INVESTIGATION STEPS WILL BE PERFORMED WITHIN THE NC. ACCORDING TO THE INSTRUCTION FOR USE (HLS SET, CHAPTER "PREPARATION AND INSTALLATION") THE PRESSURE SENSORS HAVE TO BE CHECKED BEFORE PRIMING. IN GENERAL, IT SHOULD BE NOTED THAT PRE-PRIMING CAN HAVE A NEGATIVE IMPACT ON THE SENSOR FUNCTION AND THE ASSOCIATED PRESSURE VALUES AND CAN LEAD TO THE OUTPUT OF UNEXPECTED / IMPLAUSIBLE PRESSURE VALUES SHORTLY BEFORE USE, AS INDICATED IN CHAPTER "PRIMING THE SYSTEM", WHERE IT SAYS "ONLY FILL THE SYSTEM SHORTLY BEFORE USE AND IN ACCORDANCE WITH THE PRIMING INSTRUCTIONS. CALIBRATION VALUES ARE LOST WHEN THE DRIVE UNIT IS SWITCHED OFF". FURTHER THE CARDIOHELP HAS A FLOW/BUBBLE SENSOR AND A VENOUS PROBE TO MEASURE AND CONTROL THE BLOOD FLOW AND PARAMETERS. IF THE MEASURED VALUES ARE ABOVE HIGH LIMIT OR BELOW LOW LIMIT OF THE SET LIMITS THE SYSTEM GENERATES A VISUAL AND ACOUSTICAL ALARM. ACCORDING TO THE INSTRUCTIONS FOR USE HLS SET ADVANCED 5.0 / 7.0, HIT SET ADVANCED 5.0 / 7.0 PREPARATION AND INSTALLATION ¿CARRY OUT THE CALIBRATION FOR EACH PRESSURE PARAMETER OF THE INTEGRATED SENSORS. TO DO THIS, THE SYSTEM MUST BE FREE OF LIQUIDS. FOR THIS REASON, CARRY OUT THE CALIBRATION BEFORE PRIMING THE SET.¿ 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 POLAND. IT WAS REPORTED THAT THE VENOUS PRESSURE SENSOR WAS NOTICED AS DAMAGED IN THE HLS SET. THE DAMAGE WAS DETECTED AFTER MOUNTING THE HLS SET ON THE CARDIHELP-I DEVICE FOR PRIMING AND THE PVEN VALUE COULD NOT BE RESET. THE SET WAS NOT USED FOR TREATMENT. NO PATIENT WAS INVOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS A PRESSURE READING ISSUES CAN LEAD TO A PUMP STOP IF THE INTERVENTION WAS SET BY THE USER 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
    298133 HLS SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH BE-HLS 7050 #SHLS SET ADVANCED 7.0 3000488617 04058863005744

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown