BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 12041984 · Received June 22, 2021

    Report

    Report Number
    8010762-2021-00360
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    June 15, 2021
    Report Date
    October 11, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN VIETNAM. IT WAS REPORTED THAT DURING OPERATION, THE SCREEN OF THE ROTAFLOW CONSOLE SOMETIMES DISPLAYS "ERROR HEAD" AND THE PUMP STOPS. WHEN THE USER RESTARTS THE UNIT, IT WORKS NORMALLY FOR A FEW HOURS AND THE ERROR HAPPENS AGAIN. WHEN A NEW ROTAFLOW DRIVE WAS EXCHANGED THIS ERROR "ERROR HEAD" SOMETIMES STILL DISPLAYS. NO INDICATION OF ACTUAL OR POTENTIAL FOR HARM OR DEATH HAS BEEN REPORTED. THE AFFECTED ROTAFLOW CONSOLE (RFC) WITH S/N (B)(6) WAS INVESTIGATED BY GETINGE FIELD SERVICE TECHNICIAN ON 2021-05-28. THE TECHNICIAN CONFIRMED A DEFECTIVE RFC FLOW MEASURE BOARD (ARTICLE NUMBER 701011681). THE RFC FLOW MEASURE BOARD WAS REPLACED BY THE TECHNICIAN. THE ROTAFLOW CONSOLE WAS TESTED AND CHECKED ACCORDING TO THE SERVICE MANUAL AND OPERATED ACCORDING TO FACTORIES "SPECIFICATION" AFTER REPLACING THE NEW FLOW MEASURE BOARD. THE DEVICE WAS PUT BACK IN USE. THE AFFECTED RFC FLOW MEASURE BOARD WITH ARTICLE NUMBER 701011681 WAS SEND BACK TO THE MANUFACTURER AND HAS INVESTIGATED BY THE LIFE-CYCLE-ENGINEERING (LCE). THE REPORTED FAILURE "HEAD ERROR" COULD NOT BE REPRODUCED OR CONFIRMED. THE RFC FLOW MEASURE BOARD DID NOT SHOW ANY ANOMALIES DURING THE INVESTIGATION. AFTER TESTING AND ABOUT 4 DAYS OF CONTINUOUS OPERATION THE ERROR "HEAD ERROR" COULD NOT BE REPRODUCED NOR WERE OTHER ERRORS IDENTIFIED. THE ERROR ¿HEAD ERROR¿ IS CAUSED BY A COMMUNICATION ANOMALY BETWEEN ROTAFLOW DRIVE AND THE CONTROL SYSTEM. THE ROOT CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED BUT IT CANNOT BE RULED OUT THAT A SPORADIC ERROR ON THE BOARD COULD HAVE CAUSED ANY FUNCTION ANOMALY. BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURE "HEAD ERROR" COULD NOT BE CONFIRMED. HOWEVER, THE FAILURE MODE "HEAD ERROR" CAN BE LINKED TO THE FOLLOWING MOST POSSIBLE ROOT CAUSES FOR THE HEAD ERROR: 1. THE HEAD ERROR IS CAUSED BY THE HOT PLUG. WHEN THE DEVICE IS IN OPERATION AND THE POWER PLUG IS PLUGGED IN OR OUT THE HEAD ERROR OCCURS AND THE ROTA FLOW DRIVE AND / OR THE CONTROL BOARD IS DAMAGED. AS A RESULT THE ROTA FLOW DRIVE AND / OR THE CONTROL BOARD HAS TO BE REPLACED. 2. THE HEAD ERROR FOLLOWS THE SIG ERROR. WHEN THE ULTRASONIC CREAM IS APPLIED (DUE TO THE SIG ERROR) TO THE FLOW BUBBLE SENSOR AND THE DISPOSABLE IS MOVED CLOSE TO THE ROTA FLOW DRIVE, THE MAGNETS IN THE CENTRIFUGAL PUMP INTERFERE WITH THE SENSORS IN THE ROTA FLOW DRIVE. THIS ERROR CAN BE OVERWRITTEN BY RESTARTING THE ROTA FLOW CONSOLE. 3. IF THE RPM / LPM IS SET TO ZERO AND THE DRIVE AS WELL AS THE INSERTED CENTRIFUGAL PUMP IS SHAKEN THIS CAUSES MAGNETIC UNCOUPLING OF THE CENTRIFUGAL PUMP AND THUS LEADS TO THE HEAD ERROR. THIS ERROR CAN BE OVERWRITTEN BY RESTARTING THE ROTA FLOW CONSOLE. 4. CONNECTION ISSUES BETWEEN THE ROTA FLOW CONSOLE AND THE DRIVE CAN LEAD TO A HEAD ERROR, FOR EXAMPLE DEFECTIVE PINS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON 2021-10-06. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY TO HAVE CONTRIBUTED TO THE REPORTED FAILURE. IN ORDER TO AVOID REOCCURRENCE OF THE REPORTED FAILURE, THE SALES AND SERVICE UNIT (SSU) WILL BE INFORMED TO FOLLOW THE CHAPTER IN THE INSTRUCTION FOR USE HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ 4.3 / EN / V14. CHAPTER 4.1.3: SWITCH OFF THE ROTAFLOW CONSOLE ON/OFF SWITCH BEFORE CONNECTING THE ROTAFLOW DRIVE TO OR DISCONNECTING IT FROM THE ROTAFLOW CONSOLE. OTHERWISE THE ROTAFLOW CONSOLE MAY BE DAMAGED. 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. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT DURING OPERATION, THE SCREEN OF THE ROTAFLOW CONSOLE SOMETIMES DISPLAYS "ERROR HEAD" AND THE PUMP STOPS. WHEN THE USER RESTARTS THE UNIT, IT WORKS NORMALLY FOR A FEW HOURS AND THE ERROR HAPPENS AGAIN. WHEN A NEW ROTAFLOW DRIVE WAS EXCHANGED THEN THIS ERROR "ERROR HEAD" SOMETIMES STILL DISPLAYS. NO INDICATION OF ACTUAL OR POTENTIAL FOR HARM OR DEATH HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936897 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW ENGLISH/UK UK-PLUG ICU

    Patients

    Seq Age Sex Outcome Treatment
    1