BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 19115238 · Received April 16, 2024

    Report

    Report Number
    8010762-2024-00209
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    March 27, 2024
    Report Date
    April 16, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE ERROR MESSAGE "SAFETY-S" WAS DISPLAYED ON A HL20 PUMP. THE EVENT OCCURRED DURING A ROUTINE CHECK. NO HARM TO ANY PERSON HAS BEEN REPORTED. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2024-03-28. THE BOARDS WERE CLEANED AND NO PARTS WERE REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. A SIMILAR CASE WAS ASSESSED BY THE GETINGE LIFE CYCLE ENGINEERING ON 2024-03-04. BECAUSE THE ERROR "SAFETY-S" WAS RESOLVED BY REFITTING OF ALL CIRCUIT BOARD CONNECTIONS THE MOST PROBABLE ROOT CAUSE WAS DETERMINED AS COMMUNICATION DISTURBANCES DUE TO TRANSITION RESISTANCE THAT CAN ARISE FROM SURFACE CORROSION. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2024-04-04 FOR THE PERIOD OF 2008-11-04 TO 2024-03-27. 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 2008-11-04. BASED ON THE RESULTS THE REPORTED FAILURE " ERROR MESSAGE SAFETY-S" 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 ERROR MESSAGE "SAFETY-S" WAS DISPLAYED ON A HL20 PUMP. THE EVENT OCCURRED DURING A ROUTINE CHECK. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672424 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH HL 20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown