BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 12566978 · Received October 4, 2021

    Report

    Report Number
    8010762-2021-00536
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 23, 2021
    Report Date
    February 7, 2022
    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 REPORTING THAT DURING START-UP OF THE HL 20 MACHINE THE ERROR MESSAGE "RUN-AWAY" WAS DISPLAYED. NO HARM TO ANY PERSON REPORTED. A GETINGE FIELD SERVICE TECHNICIAN (FST) INVESTIGATED THE DEVICE ON 2021-09-23. THE FST COULD NOT REPRODUCE THE REPORTED FAILURE (¿RUN-AWAY¿ ERROR MESSAGE). HE CHECKED THE DEVICE FOR POTENTIAL FAILURES IN THE RELATED AREA (FUNCTION CHECK OF THE PUMP). NO FAILURES OR PROBLEMS WERE DETECTED. AFTER A FUNCTION TEST, THE DEVICE WAS DELIVERED TO THE USER IN WORKING CONDITION. NO PARTS WERE REPLACED. THUS THE REPORTED FAILURE ERROR MESSAGE: "RUN-AWAY" COULD NOT BE CONFIRMED. GETINGE LIFE CYCLE ENGINEERING CONFIRMED THAT A POSSIBLE USE-ERROR COULD HAVE LEAD TO THE REPORTED FAILURE: IF THE PUMP IS RUNNING WHILE INSERTING A TUBE OR THE PUMP HEAD IS ROTATED MANUALLY FOR ANOTHER REASON WITH SUFFICIENT SPEED, THIS CAN LEAD TO THE ERROR MESSAGE ¿RUN-AWAY¿ OR ¿DIRECTION¿. REFERRING TO THE IFU OF THE HL20: THE PUMP HAS TO BE SWITCHED OF WHEN INSERTING THE TUBE MAINLY DUE TO SAFETY REASONS. "SWITCH OFF THE PUMP WHEN INSERTING THE TUBE. OTHERWISE, THE PUMP MAY START ACCIDENTALLY, RESULTING IN INJURY TO THE USER, AND DAMAGE TO THE TUBE OR PUMP". THE DEVICE WAS MANUFACTURED IN 2007-02-14. NON-CONFORMITIES (INCLUDE NON-CONFORMITIES IN PRODUCTION PROCESS) AT MCP WERE REVIEWED FOR THE PERIOD OF 2007-02-14 TO 2022-01-28. THERE WAS NO NON-CONFORMITY RELATED TO THE REPORTED PRODUCT AND FAILURE. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED DURING THIS TIME, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. 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

    COMPLAINT ID (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE ERROR MESSAGE "RUNAWAY" WAS REPORTED. COMPLAINT ID #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468422 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH MCP00706195#VARIO TWIN, HL 20, 4-PUMPS

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose