BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 22000741 · Received May 12, 2025

    Report

    Report Number
    8010762-2025-0000206
    Event Type
    Malfunction
    Date Received
    May 12, 2025
    Date of Event
    March 31, 2025
    Report Date
    May 12, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    UDI-DI
    04037691658384
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE HLS CABLE NEEDS TO BE REPLACED. LATER THE FAILURE WAS SPECIFIED, THAT THE HLS CABLE DELTA PRESSURE WOULD READ INTERMITTENTLY. THE FAILURE OCCURRED DURING CONNECTED TO PATIENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS WRONG PRESSURE VALUES, ARE A POTENTIAL RISK FOR THE PATIENT, A REPORT IS NEEDED.A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION. THE CUSTOMER REPLACED THE HLS CABLE THEMSELVES. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS WITH THE NEW CABLE. ALL FUNCTION TESTS ARE PASSED. THE FST CONFIRMED THAT THE HLS CABLE WAS NOT VISIBLY DAMAGED.A SIMILAR FAILURE WAS INVESTIGATED BY GETINGE LIFE CYCLE ENGINEERING (LCE).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. ADDITIONALLY, ACCORDING TO THE RISK ANALYSIS V24 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" 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. THE DEVICE WAS MANUFACTURED ON 2018-02-13.THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-05-07 FOR THE PERIOD OF 2018-02-13 TO 2025-04-01. 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. 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 "DELTA PRESSURE WOULD READ INTERMITTENTLY." COULD 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.NOTE: THIS EVENT OCCURRED ON THE CANADIAN 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HLS CABLE READ WRONG VALUES AND DOES NOT HAVE ANY VISIBLE SIGNS. THE FAILURE OCCURRED DURING TREATMENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS WRONG PRESSURE VALUES, ARE A POTENTIAL RISK FOR THE PATIENT, A REPORT IS NEEDED.COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393538 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I 04037691658384

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male