BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 11863702 · Received May 21, 2021

    Report

    Report Number
    8010762-2021-00310
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    May 14, 2021
    Report Date
    October 27, 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

    IT WAS REPORTED THAT THE PUMP DISPLAYED ERROR MESSAGE "DIRECT ERROR". A GETINGE FIELD SERVICE TECHNICIAN (FST) INVESTIGATED THE DEVICE ON 2021-05-20. THE REPORTED FAILURE "DIRECT ERROR" MESSAGE WAS RESOLVED BY REPLACING THE OPTICAL TACHO BOARD. AFTER A FUNCTION TEST, THE DEVICE WAS DELIVERED TO THE USER IN WORKING CONDITION. THUS THE REPORTED FAILURE COULD BE CONFIRMED. THE AFFECTED OPTICAL TACHO BOARD WAS NOT AVAILABLE FOR FURTHER INVESTIGATION. THEREFORE NO TECHNICAL INVESTIGATION COULD BE PERFORMED. HOWEVER THE FAILURE MODE "DIRECT ERROR" MESSAGE CAN BE LINKED TO THE FOLLOWING MOST POSSIBLE ROOT CAUSES ACCORDING TO OUR RISK MANAGEMENT FILE (DMS# DMS# 2023585): -TOTAL FAIL OF DEVICE BECAUSE OF DEFECTIVE TACHO, RELAY OR PUMP BELT. THE DEVICE WAS MANUFACTURED IN 2008-09. NON-CONFORMITIES (INCLUDE NON-CONFORMITIES IN PRODUCTION PROCESS) WERE REVIEWED FOR THE PERIOD OF 2008-09-16 TO 2021-05-21. 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

    IT WAS REPORTED THAT THE PUMP DISPLAYED ERROR MESSAGE "DIRECT ERROR". COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760857 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH HL 20

    Patients

    Seq Age Sex Outcome Treatment
    1