BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 22518552 · Received July 16, 2025

    Report

    Report Number
    8010762-2025-0000299
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    July 10, 2025
    Report Date
    August 6, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    UDI-DI
    4037691658384
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. NOTE: THIS EVENT OCCURRED ON THE GERMANY MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "BASE UNIT, CARDIOHELP¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K133598. 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 CARDIOHELP WITH CATALOG NUMBER 701048012.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE P-AUX DISPLAYS VALUES WITHOUT THE SENSOR TESTER BEING CONNECTED. THE FAILURE OCCURRED DURING SERVICE. NO HARM TO ANY PERSON HAS BEEN REPORTED. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION. THE FST CONFIRMED THAT THERE WAS NO PRESSURE FAILURES. THE FAILURE COULD NOT BE REPLICATED. NO PARTS WERE REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. AS THE FAILURE COULD NOT REPLICATED, NO EXACT ROOT CAUSE COULD BE DETERMINED. ACCORDING TO THE RISK FILE V24 OF THE CARDIOHELP DEVICE THE FOLLOWING ROOT CAUSES CAN LEAD TO THE REPORTED FAILURE: WRONG PRESSURE INFORMATION E.G.: - DEFECTIVE / DISTURBED (EMI) PRESSURE SENSOR - RESPONSE TIME IS TOO LONG - TOO HIGH / LOW ATMOSPHERIC PRESSURE. 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" AND QUADROX-IR SMALL ADULT / ADULT, CHAPTER "PRIMING THE SYSTEM") 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 2025-07-29 FOR THE PERIOD OF 2017-09-15 TO 2025-07-10. 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 2017-09-15. 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 VALUES DISPLAYED WITH NO PRESSURE TESTER CONNECTED" COULD NOT 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.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN GERMANY DURING SERVICE. IT WAS REPORTED THAT THE P-AUX DISPLAYS VALUES WITHOUT THE SENSOR TESTER BEING CONNECTED. NO HARM TO ANY PERSON HAS BEEN REPORTED. ANY PRESSURE ISSUE OR PRESSURE READING ISSUE, CAN LEAD TO A PUMP STOP IF THE FAILURE OCCURRED DURING TREATMENT AND THE INTERVENTIONS WERE SET BY THE USER. 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
    129578 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I 4037691658384

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown