BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 19017998 · Received April 2, 2024

    Report

    Report Number
    8010762-2024-00172
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    March 19, 2024
    Report Date
    September 2, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT AN INTERNAL PATIENT TRANSPORT SHOULD BE CARRIED OUT. DUE TO THE LOW BATTERY LEVEL OF THE ROTAFLOW CONSOLE (RFC) WITH S/N (B)(6), THE USER DECIDED TO REPLACE THE RFC DURING USE. THE ROTAFLOW DRIVE (RFD) WAS DISCONNECTED FROM THE RFC WITH S/N (B)(6) HOWEVER, THE RFC WAS NOT SWITCHED OFF THEREFORE, THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED AND THE RFC WAS DAMAGED. THE RFC WITH S/N (B)(6) WILL BE HANDLED IN COMPLAINT (B)(4). AFTER THE EXCHANGE THE RFD WAS CONNECTED TO THE ROTAFLOW CONSOLE WITH S/N (B)(6) HOWEVER, THIS RFC WAS ALSO NOT SWITCHED OFF THEREFORE, THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ALSO ON THE SECOND RFC WITH S/N (B)(6) AND THIS RFC WAS ALSO DAMAGED. THE RFC WITH S/N (B)(6) WILL BE HANDLED IN THIS COMPLAINT. THE SECOND DAMAGED RFC WAS ALSO REPLACED WITH ANOTHER DEVICE. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED FAILURE ¿HEAD ERROR¿ COULD LEAD TO THE PUMP STOP THEREFORE, A REPORT IS REQUIRED. A GETINGE FIELD SERVICE TECHNICIAN INVESTIGATED THE AFFECTED ROTAFLOW CONSOLE WITH S/N (B)(6) AND THE REPORTED "HEAD ERROR" COULD BE CONFIRMED. THE CUSTOMER CONFIRMED NOT TO ORDER ANY REPAIR DUE TO THE AGE OF THE DEVICE (PRODUCED IN 2014). THE DEVICE WILL BE SCRAPPED. BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE "HEAD ERROR" COULD BE CONFIRMED. 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. 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. THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. 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. NOTE: NO UDI NUMBER HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THIS MACHINE (ROTAFLOW CONSOLE) HAS BEEN MANUFACTURED ON 2014. ALL MAQUET CARDIOPULMONARY CLASS II PRODUCTS MANUFACTURED UNTIL 2015 DO NOT HAVE UDI ENTRIES. THEREFORE, NO UDI NUMBER IS AVAILABLE.

    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 GERMANY. IT WAS REPORTED THAT AN INTERNAL PATIENT TRANSPORT SHOULD BE CARRIED OUT. DUE TO THE LOW BATTERY LEVEL OF THE ROTAFLOW CONSOLE (RFC) WITH S/N (B)(6), THE USER DECIDED TO REPLACE THE RFC DURING USE. THE ROTAFLOW DRIVE (RFD) WAS DISCONNECTED FROM THE RFC WITH S/N (B)(6) HOWEVER, THE RFC WAS NOT SWITCHED OFF THEREFORE, THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED AND THE RFC WAS DAMAGED. THE RFC WITH S/N (B)(6) WILL BE HANDLED IN COMPLAINT (B)(4). AFTER THE EXCHANGE THE RFD WAS CONNECTED TO THE ROTAFLOW CONSOLE WITH S/N (B)(6) HOWEVER, THIS RFC WAS ALSO NOT SWITCHED OFF THEREFORE, THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ALSO ON THE SECOND RFC WITH S/N (B)(6) AND THIS RFC WAS ALSO DAMAGED. THE RFC WITH S/N (B)(6) WILL BE HANDLED IN THIS COMPLAINT. THE SECOND DAMAGED RFC WAS ALSO REPLACED WITH ANOTHER DEVICE. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665736 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH REFURB#RFC 20-970 ROTA FLOW CONSOLE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention