BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 19180860 · Received April 25, 2024

    Report

    Report Number
    8010762-2024-00230
    Event Type
    Malfunction
    Date Received
    April 25, 2024
    Date of Event
    April 18, 2024
    Report Date
    June 7, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A HL20 TWIN PUMP DISPLAYED THE ERROR MESSAGE "HEAD". THE EVENT OCCURRED DURING START UP. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE FAILURE CAN CAUSE AN UNINTENTIONAL PUMP STOP. THEREFORE A REPORT IS REQUIRED. ACCORDING TO THE HL20 SERVICE MANUAL THE ERROR MESSAGE "HEAD" INDICATES THAT THE MOTOR TACHO IS SHOWING A VALUE BUT THE HEAD TACHO SHOWS 0 (ZERO). A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2024-05-29. THE OPTICAL TACHO BOARD WAS REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE FAILURE WAS ALREADY INVESTIGATED IN A SIMILAR COMPLAINT BY THE GETINGE LIFE CYCLE ENGINEERING ON 2019-08-26 WITH THE FOLLOWING OUTCOME. THE MOST PROBABLE ROOT CAUSE COULD BE DETERMINED AS A BROKEN WIRING OF THE OPTICAL TACHO BOARD. DUE TO THE AGE OF THE DEVICE (ABOUT 17 YEARS) AND THIS COMPONENT OPTICAL TACHO BOARD AGE RELATED ASPECTS CAN BE CONSIDERED AS WELL. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2024-05-29 FOR THE PERIOD OF 2006-12-08 TO 2011-03-02. 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 2006-12-08. BASED ON THE RESULTS THE REPORTED FAILURE "ERROR MESSAGE HEAD" 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A GETINGE TECHNICIAN WILL INVESTIGATE THE HL 20. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4)

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HL20 TWIN PUMP DISPLAYED THE ERROR MESSAGE "ERROR HEAD". THE EVENT OCCURRED DURING START UP. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145903 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH HL 20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown