BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 13264343 · Received January 17, 2022

    Report

    Report Number
    8010762-2022-00007
    Event Type
    Malfunction
    Date Received
    January 17, 2022
    Date of Event
    January 5, 2022
    Report Date
    June 23, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN FRANCE. IT WAS REPORTED THAT THE ROTAFLOW CONSOLE TURNED OFF WHILE IT WAS CONNECTED TO A PATIENT. NO ALARM OR ERROR MESSAGE WAS REPORTED. NO HARM TO ANY PERSON HAS BEEN REPORTED. A GETINGE FIELD SERVICE TECHNICIAN INVESTIGATED THE AFFECTED ROTAFLOW CONSOLE (RFC) WITH S/N (B)(6) AND DURING THE INVESTIGATION THE REPORTED FAILURE "ROTAFLOW CONSOLE TURNED OFF" COULD NOT BE REPRODUCED. THE RFC WAS TESTED AND NEITHER ABNORMALITIES NOR ANY EVIDENCE OF ANY FAILURE OR INCORRECT FUNCTION WERE FOUND. THE MCP00702755 # BATTERY PACK FOR RFC (ROTAFLOW CONSOLE) (ARTICLE NUMBER 701017188) HAS BEEN REPLACED AS PART OF THE MAINTENANCE. THE BATTERY WAS DUE FOR REPLACEMENT IN JANUARY 2022. THE DEVICE WAS PUT BACK IN USE. THE CONCERNED ROTAFLOW CONSOLE IS NOT EQUIPPED WITH THE PROTECTION AGAINST INADVERTENT ACTUATION OF THE ON/OFF SWITCH BUTTON AND THE ROTARY KNOB AS THE ROTAFLOW CONSOLE IS NOT A ICU VARIANT. BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURE "ROTAFLOW CONSOLE TURNED OFF" COULD NOT BE CONFIRMED. HOWEVER, THE FAILURE MODE "ROTAFLOW CONSOLE TURNED OFF" CAN BE LINKED TO THE FOLLOWING MOST POSSIBLE ROOT CAUSES ACCORDING TO OUR RISK MANAGEMENT FILE (DMS# (B)(4)): UNINTENDED RPM CHANGE BY USER, UNINTENDED SWITCH OFF BY USER. THE ROTAFLOW CONSOLE WITH S/N (B)(6) WAS PRODUCED BEFORE 2008. THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2022-025-30 AND DURING THE PERIOD FROM 2008 TO 2021-05-30 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 2.2.4 GENERAL PRECAUTIONARY MEASURES DURING USE IF THE PUMP STOPS DURING AN APPLICATION, THE BLOOD FLOW WILL BE INTERRUPTED AND SUPPLY TO THE PATIENT WILL CEASE. ELIMINATE THE CAUSE OF THE PUMP STOP AND START THE PUMP AGAIN AS SOON AS POSSIBLE. 2.2 GENERAL SAFETY INSTRUCTIONS THERE IS THE RISK THAT ACOUSTIC ALARMS EMITTED BY THE ROTAFLOW SYSTEM MAY NOT BE HEARD. YOU SHOULD THEREFORE POSITION THE SYSTEM SO THAT YOU CAN SEE THE DISPLAYS ON THE ROTAFLOW CONSOLE AND ANY OPTICAL WARNING SIGNALS AT ALL TIMES. 3.3.4 BATTERY OPERATION "STATUS OF THE POWER SUPPLY DURING BATTERY OPERATION" THE ACOUSTIC ALARM CAN BE SWITCHED OFF WITH THE "AUDIO OFF" BUTTON. 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

    THE EVENT OCCURRED IN FRANCE. IT WAS REPORTED THAT THE ROTAFLOW CONSOLE TURNED OFF WHILE IT WAS CONNECTED TO A PATIENT. NO ALARM OR ERROR MESSAGE WAS REPORTED. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019400 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