BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 20576354 · Received October 31, 2024

    Report

    Report Number
    8010762-2024-0000521
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    October 30, 2024
    Report Date
    November 11, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    UDI-DI
    04058863074863
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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: NO UDI NUMBER HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THE SERIAL NUMBER OF THE AFFECTED MACHINE HAS NOT BEEN PROVIDED YET. THEREFORE, IT IS NOT POSSIBLE TO IDENTIFY THE SERIAL NUMBER OF THE MACHINE IN QUESTION AND THEREFORE ITS UDI NUMBER.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PUMP WAS NOT RISE ABOVE 0 PRM. BUBBLE ALARMS WERE DETECTED AND AFTER MULTIPLE TIMES TO CLEAR THE AIR, IT WAS NOT SUCCESSFUL. THE EMERGENCY DRIVE WAS USED. THE CARDIOHELP AND HLS SET WERE EXCHANGED TO A ROTAFLOW DEVICE. THE FAILURE OCCURRED ON START UP OF TREATMENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE AFFECTED HLS SET WILL BE INVESTIGATED IN COMPLAINT# (B)(4) (MFG REPORT NUMBER 8010762-2024-0000526). AS THE CARDIOHELP WAS EXCHANGED DURING TREATMENT, A REPORT IS REQUIRED. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION ON (B)(6)2024. THE FAILURE COULD NOT BE REPLICATED AND NO PARTS WERE REPLACED. THE FST 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 MULTIPLE PUMP START AND STOPS WERE LOGGED ON THE DATE OF EVENT, BUT NO ERROR MESSAGE WAS LOGGED. THE FAILURE COULD NOT BE REPLICATED; THEREFORE, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, ACCORDING TO THE RISK FILE OF THE CARDIOHELP DEVICE THE FOLLOWING ROOT CAUSES CAN LEAD TO THE REPORTED FAILURE: -IMPAIRED CALIBRATION/INITIALIZATION OF THE FLOW SENSOR - INSUFFICIENT FIXATION OF THE FLOW CLAMP (FLOW CLAMP NOT CLOSED). ACCORDING TO THE INSTRUCTION FOR USE (IFU) CHAPTER "CONNECTING THE COMBINED FLOW/BUBBLE SENSOR" THE BUBBLE MONITORING FUNCTION TEST AND FLOW OFF-SET CALIBRATION HAS TO BE PERFORMED BEFORE EVERY USE. THUS A DEFECTIVE FLOW/BUBBLE SENSOR SHOULD BE DETECTED PRIOR TO USE, DURING PRIMING. IN ADDITION AS THE CARDIOHELP INCLUDES PRESSURE SENSORS AND A VENOUS PROBE IT IS ABLE 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. IN THE IFU CHAPTER "USING THE EMERGENCY DRIVE WITH THE DISPOSABLE HLS RETAINER" IS STATED THAT THE EMERGENCY DRIVE CAN BE USED TO MANUALLY CONTROL THE BLOOD FLOW IN CASE OF A FAILED CARDIOHELP. REFERRING TO THE 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 CHAPTER "CONNECTING THE SENSORS" IT IS STATED THAT THE SENSORS MUST BE KEPT CLEAN. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON (B)(6) 2024 FOR THE PERIOD OF (B)(6)2022 TO (B)(6)2024. 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 (B)(6)2022. BASED ON THE RESULTS THE REPORTED FAILURE "NO FLOW - AIR CLEARING IMPOSSIBLE" COULD BE CONFIRMED, BUT NO MALFUNCTION OF THE CARDIOHELP DEVICE COULD BE DETERMINED. 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 USA DURING START UP OF TREATMENT. IT WAS REPORTED THAT THE PUMP WAS NOT RISE ABOVE 0 PRM. BUBBLE ALARMS WERE DETECTED AND AFTER MULTIPLE TIMES TO CLEAR THE AIR, IT WAS NOT SUCCESSFUL. THE EMERGENCY DRIVE WAS USED. THE CARDIOHELP AND HLS SET WERE EXCHANGED TO A ROTAFLOW DEVICE WITH A PLS SET. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS THE CARDIOHELP WAS EXCHANGED DURING TREATMENT, 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
    1962442 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I 04058863074863

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown