BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 24615806 · Received March 17, 2026

    Report

    Report Number
    8010762-2026-0000119
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    March 6, 2026
    Report Date
    April 20, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    UDI-DI
    04037691658384
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN USA BEFORE USE. IT WAS REPORTED THAT THERE WERE PRESSURE READING ISSUES. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS A PRESSURE READING ISSUE, CAN LEAD TO A PUMP STOP IF THE INTERVENTION IS SET BY THE USER, A REPORT IS REQUIRED. NEW INFORMATION RECEIVED ON 2026-04-02 THAT WHEN MOVING THE HLS CABLE IT IS ISSUING THE PRESSURE READING ISSUES. A GETINGE TECHNICIAN WAS SENT FOR INVESTIGATION ON 2026-04-06. WHEN MOVING THE HLS CABLE THE PRESSURE READING WAS OUT OF SPECIFICATION. THE HLS CABLE WAS REPLACED. THE TECHNICIAN PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE LOG FILES OF THE REPORTED CARDIOHELP DEVICE WERE REVIEWED AND NO PUMP STOP COULD BE CONFIRMED ON THE DATE OF EVENT. A SIMILAR FAILURE WAS INVESTIGATED BY GETINGE LIFE CYCLE ENGINEERING (LCE) ON 2022-11-02. THE NATURE OF THE ERROR COULD BE TRACED BACK TO A MISSING ELECTRICAL CONNECTION WITHIN THE CABLE. THE ROOT CAUSE FOR THE MISSING CONNECTION IS A BROKEN WIRE WITHIN THE CABLE, WHICH IS ORIGINATED FROM EXTERNAL FORCE. ACCORDING TO THE RISK ANALYSIS FOLLOWING ROOT CAUSES CAN ALSO LEAD TO THE REPORTED FAILURE:- A MECHANICAL DAMAGE E.G. DUE TO TOO HIGH FORCES DURING CONNECTION/ DISCONNECTION OF THE CABLE- BROKEN FIBER INSIDE THE CABLE. ACCORDING TO THE INSTRUCTION FOR USE OF THE INVOLVED DISPOSABLES (HLS SET ADVANCED 5.0 / 7.0, HIT SET ADVANCED 5.0 / 7.0, V2.4, CHAPTER "PREPARATION AND INSTALLATION") THE PRESSURE SENSORS HAVE TO BE CALIBRATED AND CHECKED BEFORE PRIMING. FURTHERMORE, 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. ADDITIONALLY, ACCORDING TO THE INSTRUCTION FOR USE (IFU) OF THE CARDIOHELP, CHAPTER "CONNECTION THE SENSORS", IT IS STATED TO ENSURE THAT THE CONNECTED SENSORS ARE NOT DEFECTIVE AND TO NOT USE IF THERE IS A VISIBLE DAMAGE. IN THE INSTRUCTIONS FOR USE (IFU) OF THE CARDIOHELP (CHAPTER "CLEANING AND DISINFECTION") THE CABLES AND THE WHOLE DEVICE SHOULD BE CLEANED AFTER EACH USE TO REMOVE SOILING OR RESIDUAL BLOOD. FURTHERMORE, IN THE IFU CHAPTER "CONNECTING THE SENSORS" IT IS STATED THAT THE SENSORS MUST BE KEPT CLEAN. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2026-04-02 FOR THE PERIOD OF 2017-06-06 TO 2026-03-06. 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 2017-06-06. 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 "PRESSURE READING ISSUE" 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.

    Additional Manufacturer Narrative · 0

    A GETINGE SERVICE TECHNICIAN WILL INVESTIGATE THE AFFECTED CARDIOHELP. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN USA BEFORE USE. IT WAS REPORTED THAT THERE WERE PRESSURE READING ISSUES. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS A PRESSURE READING ISSUE, CAN LEAD TO A PUMP STOP IF THE INTERVENTION IS SET BY THE USER, A REPORT IS REQUIRED. COMPLAINT ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57127 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I 04037691658384

    Patients

    Seq Age Sex Outcome Treatment
    1