BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 17077400 · Received June 7, 2023

    Report

    Report Number
    8010762-2023-00266
    Event Type
    Malfunction
    Date Received
    June 7, 2023
    Date of Event
    June 7, 2023
    Report Date
    June 12, 2023
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN JAPAN. IT WAS REPORTED THAT THE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW CONSOLE AS THE DEVICE WAS NOT IN CLINICAL USE. NO PATIENT WAS INVOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. A GETINGE FIELD SERVICE TECHNICIAN INVESTIGATED THE AFFECTED ROTAFLOW CONSOLE WITH S/N 100016 ACCORDING TO THE FACTORY SPECIFICATIONS. THE TECHNICIAN WAS UNABLE TO REPRODUCE THE REPORTED "HEAD ERROR". NO PARTS HAS BEEN REPLACED. THE DEVICE IS WORKING AS INTENDED AND IS BACK IN USE. BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURE "HEAD ERROR" COULD NOT BE CONFIRMED. HOWEVER, THE FOLLOWING MOST POSSIBLE ROOT CAUSE COULD BE DETERMINED FOR THE HEAD ERROR: 1. 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. 2. 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. THE ROTAFLOW CONSOLE WITH S/N 10016 WAS PRODUCED IN 2012-04-10. THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2023-06-07 AND DURING THE PERIOD FROM 2012-04-10 TO 2023-06-07 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 ARE UNLIKELY. IN ORDER TO AVOID REOCCURRENCE OF THE REPORTED FAILURE, THE CUSTOMER WILL BE INFORMED BY THE GETINGE SALES AND SERVICE UNIT (SSU) TO FOLLOW THE CHAPTER IN THE INSTRUCTION FOR USE HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ 4.4 / EN / 15. 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. CHAPTER 2.2.2: DO NOT REMOVE THE DISPOSABLE DURING THE APPLICATION. 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.

    Additional Manufacturer Narrative · 0

    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 · 0

    COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN JAPAN. IT WAS REPORTED THAT THE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW CONSOLE AS THE DEVICE WAS NOT IN CLINICAL USE. NO PATIENT WAS INVOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956646 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH MCP00703157#RFC 20-970 ROTAFLOW CONSOLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown