BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 18967008 · Received March 25, 2024

    Report

    Report Number
    8010762-2024-00158
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    March 11, 2024
    Report Date
    April 15, 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

    THE INVESTIGATION IS ONGOING. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2024-03-13. THE OPTICAL TACHO BOARD AND MOTOR CONTROL BOARD WERE REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2024-03-25 FOR THE PERIOD OF 2015-05-19 TO 2024-03-11. 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 2015-05-19. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A HL 20 PUMP DISPLAYED THE ERROR MESSAGE "ERROR HEAD". THE EVENT OCCURRED DURING A ROUTINE CHECK. NO HARM TO ANY PERSON HAS BEEN REPORTED. DURING SERVICE ALSO THE ERROR MESSAGE "BELTSLIP" WAS DISPLAYED. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2024-03-13. THE OPTICAL TACHO BOARD AND MOTOR CONTROL BOARD WERE REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE AFFECTED PART WAS NOT MADE AVAILABLE FOR FURTHER INVESTIGATION AT THE MANUFACTURER. THE REPORTED FAILURE "ERROR HEAD" AND "BELTSLIP" COULD BE LINKED TO THE FOLLOWING MOST PROBABLE ROOT CAUSES ACCORDING TO THE RISK MANAGEMENT FILE: FAIL OF DEVICE BECAUSE OF: FAILURE OF PUMP CONTROL BOARD (PUMP STOP). FAILURE OPTICAL TACHO BOARD. DEFECTIVE TACHO, RELAY OR PUMP BELT. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2024-03-25 FOR THE PERIOD OF 2015-05-19 TO 2024-03-11. 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 2015-05-19. BASED ON THE RESULTS THE REPORTED FAILURE "ERROR MESSAGE ERROR HEAD AND BELTSLIP" 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 A HL 20 PUMP DISPLAYED THE ERROR MESSAGE "ERROR HEAD". THE EVENT OCCURRED DURING A ROUTINE CHECK. NO HARM TO ANY PERSON HAS BEEN REPORTED. DURING SERVICE ALSO THE ERROR MESSAGE "BELTSLIP" WAS DISPLAYED. 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
    441682 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH HL 20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown