BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 12427140 · Received September 6, 2021

    Report

    Report Number
    8010762-2021-00482
    Event Type
    Malfunction
    Date Received
    September 6, 2021
    Date of Event
    August 25, 2021
    Report Date
    September 6, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL FAILURE DESCRIPTION WAS THAT THE ROTFLOW DISPLAYED THE ERROR MESSAGE "ARITHMET" IN THE ART PULS MODE. A GETINGE SERVICE TECHNICIAN REPAIRED THE AFFECTED ROTAFLOW SERIAL# B)(4) ON 2021-08-25 IN THE NATIONAL REPAIR CENTER. THE TECHNICIAN REPLACED THE RFC (ROTAFLOW CONSOLE) CONTROL BOARD KIT (MATERIAL#70103.4051). AFTER THE REPLACEMENT THE DEVICE IS WORKING AS INTENDED. AN INVESTIGATION OF A ROTAFLOW SYSTEM THAT EXHIBITED A SIMILAR ISSUE WAS PERFORMED IN GETINGE LIFE CYCLE ENGINEERING ON 2020-07-14. THE MOST PROBABLE ROOT CAUSE COULD BE DETERMINED AS A FAULTY EEPROM MEMORY (IC9) OF THE CONTROL BOARD. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2021-09-03 FOR THE PERIOD OF 2018-05-15 TO 221-08-25. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THERE IS NO INDICATION ON MANUFACTURING ISSUES OCCURRED DURING THIS TIME, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE PRODUCT IN QUESTION WAS PRODUCED IN 2018-05-15 BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURE COULD 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 A ROTAFLOW DISPLAYED THE ERROR MESSAGE ¿ARITHMET (MICRO CONTROLLER ERROR)¿ DURING THE PREVENTATIVE MAINTENANCE. NO PATIENT HAS BEEN INVOLVED. COMPLAINT ID:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324382 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW

    Patients

    Seq Age Sex Outcome Treatment
    1