BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 11692023 · Received April 20, 2021

    Report

    Report Number
    8010762-2021-00257
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 31, 2021
    Report Date
    April 20, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL FAILURE DESCRIPTION WAS THAT THE "ROTAFLOW DRIVE LOOSES CONNECTION". THE FAILURE OCCURRED DURING PATIENT TREATMENT AND THE DEVICE HAS BEEN EXCHANGED WITH A BACKUP DEVICE. A GETINGE SERVICE TECHNICIAN WAS ONSITE TO INVESTIGATE THE AFFECTED ROTAFLOW ON 2021-04-12. THE SERVICE TECHNICIAN WAS UNABLE TO REPRODUCE THE REPORTED FAILURE. HOWEVER THE FAILURE MODE "ROTAFLOW DRIVE LOOSES CONNECTION" CAN BE LINKED TO THE FOLLOWING MOST POSSIBLE ROOT CAUSES ACCORDING TO OUR RISK MANAGEMENT FILE (DMS# (B)(4). MALFUNCTION OR TOTAL FAIL DUE TO MECHANICAL INFLUENCES, COLLISION WITH ENVIRONMENT DURING PATIENT TRANSPORT, USER TRIPS OVER CABLES OR TUBES, LOOSENING OF FASTENING (WRONG INSTALLATION, AGING). THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2021-04-19 FOR THE PERIOD OF 2014-10-01 TO 2021-04-19. IT 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. THE PRODUCT IN QUESTION WAS PRODUCED IN 2014-10-01. BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURE COULD NOT BE CONFIRMED. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROTAFLOW DRIVE LOOSES THE CONNECTION TO THE ROTAFLOW CONSOLE. THE DEVICE HAS BEEN EXCHANGED WITH A BACKUP DEVICE. NO PATIENT HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591930 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention