BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 12539456 · Received September 28, 2021

    Report

    Report Number
    8010762-2021-00526
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Date of Event
    September 21, 2021
    Report Date
    November 23, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL FAILURE DESCRIPTION WAS THAT THE ROTAFLOW DISPLAYS THE ERROR MESSAGE "REFERENCE" AFTER THE START UP OF THE DEVICE. NO PATIENT HAS BEEN INVOLVED. A GETINGE SERVICE TECHNICIAN CONFIRMED ON 2021-11-04 THE REPORTED FAILURE AND REPLACED THE RFC (ROTAFLOW CONSOLE) POWER SUPPLY BOARD(MATERIAL#70101.1675). AFTER THE REPLACEMENT THE DEVICE IS WORKING AS INTENDED. THE RFC POWER SUPPLY BOARD HAS BEEN REQUESTED BUT IS NO LONGER AVAILABLE. HOWEVER THE FAILURE MODE "REFERENC" CAN BE LINKED TO THE FOLLOWING MOST POSSIBLE ROOT CAUSES ACCORDING TO OUR RISK MANAGEMENT FILE (DMS# (B)(4)). (UN)INTENTIONAL STOP OF THE PUMP, E.G.: 1. DEFECTIVE MOTOR CONTROL ELECTRONICS. 2. PUMP STOP INTERVENTION AFTER TECHNICAL ERROR (E.G. PUMP RUNAWAY, ERROR HEAD). MALFUNCTION OF THE MICROCOMPUTER SYSTEM: 1. INTERNAL CPU FAILURE. 2. NON-VOLATILE MEMORY FAILURE´. 3. VOLATILE MEMORY FAILURE. 4. FAILURE OF INTERNAL COMPONENTS (ADC, ETC.). BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURE COULD BE CONFIRMED. THE PRODUCT IN QUESTION WAS PRODUCED IN 2015-09-01. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2021-11-23 FOR THE PERIOD OF 2015-09-01 TO 2021-09-22. 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 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 · 0

    COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROTAFLOW DISPLAYED THE ERROR MESSAGE ¿REFERENCE¿ AFTER THE START OF THE ROTAFLOW. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439984 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW PUMP MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown