BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 19654739 · Received July 2, 2024

    Report

    Report Number
    8010762-2024-00340
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 10, 2024
    Report Date
    July 2, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE VENOUS BUBBLE SENSOR WAS DEFECTIVE. IT WAS REPORTED THAT THE SENSOR WOULD RANDOMLY ALARM "VENOUS BUBBLE DETECTED" THEN SUBSEQUENTLY, ALARMED "VENOUS BUBBLE SENSOR DEFECTIVE". THE FAILURE OCCURRED DURING TREATMENT. THE VENOUS BUBBLE SENSOR WAS SWAPPED OUT. NO HARM TO ANY PERSON HAS BEEN REPORTED. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION ON 2024-06-16 AND 2024-06-21. THE FST CONFIRMED THE FAILURE. THE FST TESTED THE VENOUS BUBBLE SENSOR BY MOVING THE SENSOR CABLE IN CERTAIN AREAS. THE SENSOR WOULD ALARM "VENOUS BUBBLE SENSOR DEFECTIVE" WHEN THE CABLE WAS MOVED. THE FST CONFIRMED THAT THERE WERE VISIBLE DAMAGE OR CONTAMINATION ON THE SENSOR. THE VENOUS BUBBLE SENSOR WAS 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 ¿VENOUS BUBBLE DETECTED¿ AND ¿VENOUS BUBBLE SENSOR DEFECTIVE¿ COULD BE CONFIRMED. ANOTHER VENOUS BUBBLE SENSOR WITH A SIMILAR FAILURE WAS ALREADY INVESTIGATED. FOLLOWING POSSIBLE ROOT CAUSES WERE DETERMINED: -DAMAGED WIRING INSIDE THE CABLE DUE TO MECHANICAL TENSION. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), CHAPTERS "MONITORING AND SENSORS" AND "BUBBLE MONITORING: FUNCTION TEST" THE VENOUS BUBBLE SENSOR AND THE ARTERIAL FLOW/BUBBLE SENSOR HAVE TO BE TESTED BEFORE EACH USE. THE CARDIOHELP HAS A FLOW/BUBBLE SENSOR FOR BUBBLE DETECTION. THE VENOUS BUBBLE SENSOR IS OPTIONAL AND FOR ADDITIONAL BUBBLE DETECTION. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2024-06-11 FOR THE PERIOD OF 2017-09-11 TO 2024-06-10. 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 2017-09-11. BASED ON THE RESULTS THE REPORTED FAILURE "VENOUS BUBBLE SENSOR DEFECTIVE" 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENOUS BUBBLE SENSOR WOULD RANDOMLY ALARM ¿VENOUS BUBBLE DETECTED¿, AND EVENTUALLY ALARMED ¿VENOUS BUBBLE SENSOR DEFECTIVE¿. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE FAILURE OCCURRED DURING TREATMENT. AS THE FAILURE OCCURRED DURING TREATMENT AND ANY BUBBLE DETECTING ISSUES CAN LEAD TO A PUMP STOP IF THE INTERVENTIONS WERE SET BY THE USER. THERE IS A POTENTIAL RISK, A REPORT IS REQUIRED. COMPLAINT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507436 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown