BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 16353244 · Received February 10, 2023

    Report

    Report Number
    8010762-2023-00080
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    January 27, 2023
    Report Date
    February 10, 2023
    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 "HEAD ERROR" WAS DISPLAYED ON THE HL20 PUMP AFTER STARTUP OF THE DEVICE. NO HARM TO ANY PERSON WAS REPORTED. A GETINGE FIELD SERVICE TECHNICIAN WAS ONSITE AND INVESTIGATED THE UNIT IN QUESTION. THE HL 20 MACHINE WAS CHECKED THROUGHLY AND ALL THE CONNECTIONS WERE RESETTED INSIDE THE PUMP. NO PROBLEM WAS FOUND. THE HL 20 MACHINE IS WORKING ACCORDING TO FACTORY¿S SPECIFICATION . NO PARTS WERE REPLACED. THE DEVICE WAS PUT BACK INTO USE. THUS THE REPORTED FAILURE COULD NOT BE CONFIRMED. HOWEVER THE FAILURE MODE "HEAD ERROR" CAN BE LINKED TO THE FOLLOWING MOST POSSIBLE ROOT CAUSES ACCORDING TO THE HL 20 RISK MANAGEMENT FILE: FAILURE OF PUMP CONTROL BOARD. DEFECTIVE/ DIRTY TACHO, RELAY OR PUMP BELT. DEVICE WAS MANUFACTURED IN 2007-02-14 (MAT#MCP00706195#VARIO TWIN, HL 20) THE REVIEW OF THE NON-CONFORMITIES DURING THE PERIOD OF 2007-02-14 TO 2023-01-27 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 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 "HEAD ERROR" WAS DISPLAYED ON THE HL20 PUMP AFTER STARTUP OF THE DEVICE. NO HARM TO ANY PERSON WAS REPORTED. COMPLAINT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997079 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH HL 20

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose