BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART LUNG MACHINE

    MDR report key: 12466889 · Received September 14, 2021

    Report

    Report Number
    3008355164-2021-00024
    Event Type
    Death
    Date Received
    September 14, 2021
    Date of Event
    September 12, 2021
    Report Date
    December 28, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT THE ROTAFLOW CONSOLE REPORTED AN ¿TXRX ERROR¿. INITIALLY IT WAS REPORTED THAT THE AFFECTED CONSOLE IS STILL USED ON PATIENT. LATER, NEW INFORMATION WAS RECEIVED THAT THE PATIENT HAS DIED. THE PATIENT DIED IN THE EARLY MORNING OF (B)(6) 2021. TECHNICIAN GOT THIS FINAL INFORMATION AFTER GETTING IN TOUCH WITH THE HEAD NURSE OF THE HOSPITAL ON (B)(6) 2021. IT WAS CONFIRMED BY THE CUSTOMER THAT THEY DID NOT USE THIS ROTAFLOW FOR THE PROCEDURE DUE TO EQUIPMENT FAILURE. THE ROTAFLOW CONSOLE WITH S/N (B)(6) WAS INVESTIGATED BY A GETINGE FIELD SERVICE TECHNICIAN ON (B)(6) 2021 AND WAS ABLE TO REPRODUCE THE REPORTED FAILURE. THE (B)(6)# FLOW MEASURE BOARD FOR RFC (ROTAFLOW CONSOLE) (ARTICLE NUMBER (B)(6)) HAS BEEN REPLACED. AFTER THE REPLACEMENT THE DEVICE IS WORKING AS INTENDED. THE AFFECTED PART (B)(6)# FLOW MEASURE BOARD FOR RFC (ROTAFLOW CONSOLE) (ARTICLE NUMBER (B)(6) WAS SEND BACK TO THE MANUFACTURER FOR INVESTIGATION. THE PART WAS INVESTIGATED BY THE GETINGE LIFE-CYCLE-ENGINEERING (LCE) AND THE REPORTED FAILURE "TXRX ERROR" COULD BE CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED AS DEFECT OF THE SIGNAL AMPLIFIER IC26 ON THE FLOW MEASURE BOARD WHICH LED TO THE REPORTED FAILURE. THE PROBABLE CAUSE FOR THE DEFECT IS STATISTICAL COMPONENT FAILURE. THE REPORTED FAILURE AND THE APPLICATION METHOD DESCRIBED BY THE CUSTOMER WAS EVALUATED BY GETINGE MEDICAL AFFAIRS DEPARTMENT ON (B)(6) 2021 FOLLOWING OUTCOME: THE LIMITED CORRESPONDENCE FROM THE CLINIC INDICATES THAT TREATMENT WAS NOT INITIATED BECAUSE OF THE REPORTED FAILURE MODE. THE CLINIC REPORTED ALL AVAILABLE ROTAFLOW SYSTEMS WERE IN USE. THE CONTINGENCY PLAN REPORTED BY THE CLINIC WHEN AN ADDITIONAL SYSTEM IS REQUIRED EMERGENTLY REQUIRES BORROWING A SYSTEM FROM ANOTHER CLINIC. THE DEVICE WAS NOT FUNCTIONING CORRECTLY AS DESCRIBED IN THE COMPLAINT. THE REVIEWER CANNOT CONCLUDE THE PATIENT OUTCOME WAS SOLELY OR PARTIALLY RELATED TO THE REPORTED ROTAFLOW FAILURE MODE. A DELAY IN TREATMENT MAY BE ASSOCIATED WITH MORBIDITY AND MORTALITY IN ACUTELY ILL PATIENTS REQUIRING EXTRACORPOREAL SUPPORT; HOWEVER, THE CORRESPONDENCE FROM THE CLINIC LACKS THE DETAIL TO COME TO A DEFINITIVE CONCLUSION. BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE "TXRX ERROR" COULD BE CONFIRMED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON (B)(6) 2021. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY TO HAVE CONTRIBUTED TO THE REPORTED FAILURE. 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 THE ROTAFLOW CONSOLE REPORTED AN ¿TXRX ERROR¿. INITIAL IT WAS REPORTED THAT THE AFFECTED CONSOLE IS STILL USED ON PATIENT. LATER, NEW INFORMATION RECEIVED THAT THE PATIENT HAS DIED. THE PATIENT DIED IN THE EARLY MORNING OF (B)(6) 2021. TECHNICIAN GOT THIS FINAL INFORMATION AFTER GETTING IN TOUCH WITH THE HEAD NURSE OF THE HOSPITAL ON (B)(6) 2021. IT WAS CONFIRMED BY THE CUSTOMER THAT THEY DID NOT USE THIS ROTAFLOW FOR THE PROCEDURE DUE TO EQUIPMENT FAILURE. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365843 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH MCP00706291#ROTAFLOW PUMP MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death