BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 12364483 · Received August 25, 2021

    Report

    Report Number
    8010762-2021-00473
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    August 23, 2021
    Report Date
    November 22, 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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN VIETNAM. IT WAS REPORTED THAT WHEN ADJUSTING THE ROTATION SPEED >1000 RPM (ROUNDS PER MINUTES) ON THE ROTAFLOW CONSOLE, THE DEVICE SHOWS THE ERROR MESSAGE "ERROR HEAD" AND STOPS PUMPING (IF ADJUSTING THE ROTATION SPEED <1000RPM, THE DEVICE DOESN'T APPEAR THE ERROR "ERROR HEAD"). THE FAILURE OCCURRED DURING THE PREPARATION OF THE DEVICE. THE ROTAFLOW DRIVE IS DETECTED AS DEFECTIVE. NO HARM HAS BEEN REPORTED. THE ROTAFLOW DRIVE (RFD) WITH S/N (B)(6) WAS SENT BACK TO MANUFACTURER FOR REPAIR. DURING THE INVESTIGATION BY THE GETINGE SERVICE DEPARTMENT ON 2021-10-14 THE REPORTED "HEAD ERROR" COULD BE REPRODUCED. THUS, THE DRIVE WAS SENT TO THE SUPPLIER EMTEC FOR REPAIR. ON 2021-11-12 THE SUPPLIER EMTEC WAS ABLE TO REPRODUCE THE REPORTED FAILURE "HEAD ERROR" AND THE ROOT CAUSE COULD BE DETERMINED AS MISUSE OF THE DEVICE, WHICH LEAD TO A DAMAGE OF THE ELECTRONIC PARTS. THESE PARTS WERE REPLACED BY THE SUPPLIER. AFTER FUNCTIONAL TEST AT GETINGE SERVICE DEPARTMENT ON 2021-11-19 THE DEVICE WAS SENT BACK TO THE USER. THE FOLLOWING MOST POSSIBLE ROOT CAUSE COULD BE DETERMINED FOR THE HEAD ERROR: 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. BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURE "HEAD ERROR" COULD BE CONFIRMED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON 2021-11-22. 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/ 4.2 / 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 WHEN ADJUSTING THE ROTATION SPEED >1000 RPM (ROUNDS PER MINUTES) ON THE ROTAFLOW CONSOLE, THE DEVICE SHOWS THE ERROR MESSAGE "ERROR HEAD" AND STOPS PUMPING (IF ADJUSTING THE ROTATION SPEED <1000RPM, THE DEVICE DOESN'T APPEAR THE ERROR "ERROR HEAD"). THE ROTAFLOW DRIVE IS DETECTED AS DEFECTIVE. 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
    1264071 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW DRIVE UNIT, BLUE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown