BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART LUNG MACHINE

    MDR report key: 12445868 · Received September 9, 2021

    Report

    Report Number
    3008355164-2021-00023
    Event Type
    Death
    Date Received
    September 9, 2021
    Date of Event
    September 4, 2021
    Report Date
    February 3, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    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 INITIAL FAILURE DESCRIPTION WAS THAT THE ROTAFLOW DISPLAYED THE ERROR MESSAGE "TXRX ERROR" DURING PATIENT TREATMENT. THE PATIENT EXPIRED. A GETINGE SERVICE TECHNICIAN WAS ON SITE ON (B)(6) 2021 TO REPAIR THE AFFECTED ROTAFLOW (SERIAL#(B)(6)). THE TECHNICIAN CONFIRMED THE REPORTED FAILURE AND REPLACED THE RFC (ROTAFLOW CONSOLE) FLOW MEASURE BOARD (MATERIAL#70101.1681). AFTER THE REPLACEMENT THE DEVICE IS WORKING AS INTENDED. THE AFFECTED RFC FLOW MEASURE BOARD (MATERIAL#70101.1681) WAS RETURNED FOR FURTHER INVESTIGATION IN THE LIFE-CYCLE- ENGINEERING. THE FOLLOWING MOST PROBABLE ROOT CAUSE COULD BE DETERMINED: IT WAS CONFIRMED THAT THE FLOW MEASURE BOARD CAUSED THE MESSAGE ¿TXRX¿ IN THE LPM DISPLAY INSTEAD OF THE MEASURED FLOW. THE SIGNAL S1GATE WAS FOUND TO BE FAULTY. THE PROBABLE ROOT CAUSE IS A DEFECT IN ONE OF THE COMPONENTS IC13 OR IC20. A CONCLUSIVE IDENTIFICATION OF THE ROOT CAUSE WAS NOT POSSIBLE BECAUSE THE ISSUE DIDN´T REOCCUR AFTER SOME TIME. THE REPORTED FAILURE AND THE APPLICATION METHOD DESCRIBED BY THE CUSTOMER WAS EVALUATED BY GETINGE MEDICAL AFFAIRS DEPARTMENT ON 2021-10-04 FOLLOWING OUTCOME: THE SYSTEM SPECIFICATIONS INDICATE THE ROTAFLOW BLOOD FLOW WILL CONTINUE BASED ON THE MOTOR SPEED SET POINT DESPITE A FLOW SENSOR BOARD FAILURE AS REPORTED IN THIS COMPLAINT. THE CORRESPONDENCE DID NOT ELABORATE ON HOW THE ROTAFLOW SYSTEM WAS OPERATED OR HOW THE PATIENT WAS CLINICALLY MANAGED ONCE THE ERROR CODE OCCURRED DURING APPLICATION. THE LIMITED CORRESPONDENCE FROM THE CLINICAL DIRECTOR SUPPORTS THE CONCLUSION THAT THE PATIENT DEATH WAS NOT A RESULT OF THE FAILURE MODE IDENTIFIED IN THIS REPORT. THE CLINICIAN ATTRIBUTED THE OUTCOME SOLELY TO PATIENT ACUITY. THE ROOT CAUSE OF THE ROTAFLOW SYSTEM FAILURE MODE IN THIS INSTANCE MAY BE ASSOCIATED WITH A USE ERROR AND HOT SWAPPING THE DRIVE WHILE THE SYSTEM WAS POWERED ON. A DEVICE HISTORY REVIEW (DHR) WAS PERFORMED ON 2022-01-26 AND THE DHR DOES NOT SHOW ANY ABNORMALITY OR ISSUE THAT IS RELATED OR COULD HAVE LED TO THE CUSTOMER COMPLAINT. 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. 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.

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ERROR MESSAGE ¿TXRX ERROR¿ WAS DISPLAYED ON THE ROTAFLOW CONSOLE. THE FAILURE OCCURRED DURING PATIENT TREATMENT. THE PATIENT DIED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341719 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death