BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 11468602 · Received March 12, 2021

    Report

    Report Number
    8010762-2021-00184
    Event Type
    Malfunction
    Date Received
    March 12, 2021
    Date of Event
    February 28, 2021
    Report Date
    May 4, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THE ERROR MESSAGE "OVERLOAD" WAS REPORTED. A GETINGE FIELD SERVICE TECHNICIAN (FST) HAS BEEN SENT FOR INVESTIGATION ON 2021-03-05 AND FOLLOWING WORKS HAS BEEN DONE: THE MOTOR CONTROL BOARD WAS REPLACED WITH A NEW ONE AND THE PROBLEM WAS SOLVED. THE SYSTEM WAS CHECKED ACCORDING TO FACTORY¿S SPECIFICATION AND ALL TESTS PASSED. THE DEVICE WAS PUT BACK INTO USE. THE REPLACED MOTOR CONTROL BOARD OF THE HL 20 ROLLER PUMP MODULE WAS NOT AVAILABLE FOR FURTHER INVESTIGATION. HOWEVER THE FAILURE MODE "OVERLOAD ERROR MESSAGE" CAN BE LINKED TO THE FOLLOWING MOST POSSIBLE ROOT CAUSES ACCORDING TO OUR RISK MANAGEMENT FILE (DMS#: (B)(4). WRONG PUMP SPEED BECAUSE OF: COMMUNICATION ERROR (E.G. WRONG RATIO BETWEEN MASTER-SLAVE PUMPS DUE TO COMMUNICATION ERROR) PUMP BLOCKED. DEVICE WAS MANUFACTURED IN 2008-09-16. THE REVIEW OF THE NON-CONFORMITIES DURING THE PERIOD OF 2008-09-16 TO 2021-03-10 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 CAN BE EXCLUDED BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURE "OVERLOAD ERROR MESSAGE" COULD NOT BE CONFIRMED. 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#: (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 "OVERLOAD" WAS REPORTED. THE MACHINE WAS CHECKED AND IT WAS FOUND THAT THE MOTOR CONTROL BOARD IS DEFECTIVE AND NEEDS TO BE REPLACED. COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372859 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