BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 12446294 · Received September 9, 2021

    Report

    Report Number
    8010762-2021-00493
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 25, 2021
    Report Date
    January 19, 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 REPORTED THAT THE HL20 PUMP SHOWED ERROR MESSAGE: SAFETY-S. NO HARM TO ANY PERSON REPORTED. A GETINGE FIELD SERVICE TECHNICIAN WAS ONSITE AND INVESTIGATED THE UNIT IN QUESTION ON 2021-08-26. 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 COULD NOT BE CONFIRMED. HOWEVER THIS REPORTED ERROR MESSAGE COULD BE LINKED TO THE FOLLOWING ROOT CAUSE: - AN ERROR OCCURS WHEN TRANSMITTING THE SIGNALS VIA THE CONTROL BOARD TO THE SAFETY SYSTEM BOARD. THIS CAUSES THAT THE SAFETY SYSTEM BOARD TO RECEIVE NO OR INCORRECT DATA AND THEREFORE TRIGGERS THE ERROR MESSAGE: "SAFETY-S". WITH REFERENCE TO THE HL20 RISK ASSESSMENT (RISK ID: H1.1.1.2.7) THIS EVENT CAN BE CONTRIBUTED TO: WRONG PUMP SPEED BECAUSE OF: - COMMUNICATION ERROR (E.G. WRONG RATIO BETWEEN MASTER-SLAVE PUMPS DUE TO COMMUNICATION ERROR). DEVICE WAS MANUFACTURED IN 2007-01-29. THE REVIEW OF THE NON-CONFORMITIES DURING THE PERIOD OF 2007-01-29 TO 2022-01-19 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

    COMPLAINT ID #(B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE HL20 SINGLE PUMP MODULE DISPLAYED THE ERROR MESSAGE: "SAFETY S". PUMP STOPPED. NO HARM TO ANY PERSON WAS REPORTED. A GETINGE FIELD SERVICE TECHNICIAN WILL BE SENT ONSITE FOR INVESTIGATION OF THE DEVICE. AS SOON AS NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HL20 SINGLE PUMP MODULE DISPLAYED THE ERROR MESSAGE: "SAFETY S". PUMP STOPPED. NO HARM TO ANY PERSON WAS REPORTED. REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344524 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