BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 10435843 · Received August 21, 2020

    Report

    Report Number
    8010762-2020-00268
    Event Type
    Malfunction
    Date Received
    August 21, 2020
    Date of Event
    August 13, 2020
    Report Date
    August 21, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE SERVICE ORDER 43426653 DATED ON 2020-08-19 A GETINGE SERVICE TECHNICIAN COULD NOT CONFIRM THE OVERHEATING OF THE ROTAFLOW, BUT FOUND THE ERROR MESSAGE "TXRX". THE DEVICE WAS INSPECTED. ALL CONNECTIONS AND FANS ARE WORKING PROPERLY. THE 701011681 RFC FLOW MEASURE BOARD HAS BEEN REPLACED. THE ELECTRONIC AND FUNCTIONAL TEST OF THE DEVICE WERE PASSED. THE REPORTED FAILURE "TXRX ERROR" WAS ALREADY INVESTIGATED BY OUR LCE: THE TXRX-ERROR WAS RELATED TO A DEFECTIVE FLOW MEASUREMENT BOARD (FMB). IT COULD BE DETERMINED BY INVESTIGATIONS BY LIFE CYCLE ENGINEERING (LCE) OF IDENTICAL FMB¿S IN OTHER COMPLAINTS. ACCORDING TO INVESTIGATION REPORT LCE 2827 (INVESTIGATION PERFORMED ON 2015-11-18, REFER TO COMPLAINT SAP RECORD# (B)(4)) THE CAPACITOR C2 HAD A SHORT CIRCUIT. DUE TO THAT THE ¿-12 V FAILURE¿ APPEARED AND THE FUSE F1 WAS TRIGGERED. ACCORDING TO LCE 3852 (INVESTIGATION PERFORMED ON 2018-07-12, REFER TO TRACKWISE RECORD#162681) THE FMB WAS DAMAGED BY A SERVICE TECHNICIAN. WHEN REMOVING IT THE SOLDERING JOINT OF POTENTIOMETER POT3 WAS BROKEN. OTHER MALFUNCTIONS OF THE FMB, THE ROTAFLOW DRIVE OR WIRES WOULD LEAD TO THE ERROR MESSAGES ¿----¿ OR ¿-**-¿ ON THE FLOW DISPLAY. THUS OTHER COMPONENTS CAN BE EXCLUDED AS PROBABLE ROOT CAUSE. THE FAILURE COULD BE CONFIRMED. THE MOST PROBABLE ROOT CAUSE FOR THE "TXRX ERROR" COULD BE A BROKEN POTENTIOMETER POT 3 AS THE ERROR OCCURRED DURING THE SERVICE. THE ROTAFLOW RISK ANALYSIS VERSION (B)(4) (DMS# 2023689) CHAPTER H1.1.1.10 WAS REVIEWED ON 2020-08-19 WITH FOLLOWING MOST PROBABLE ROOT CAUSES FOR THE FAILURE "OVERHEATING": OVER TEMPERATURE CONDITION IN THE DEVICE, INCREASED HEAT GENERATION DUE TO SHORT CIRCUITS, DEFECT BATTERY, HEAT ACCUMULATION, HEAT GENERATION DUE TO MOTOR BLOCKAGE, DEVICE USED OUT OF SPECIFICATION, CHARGING OF BATTERY. THE REPORTED FAILURE ¿OVERHEATING" OCCURRED DURING PATIENT TREATMENT AND COULD NOT BE CONFIRMED. THE ERROR MESSAGE "TXRX" OCCURRED DURING THE SERVICE AND COULD BE CONFIRMED. THE DEVICE WAS DIRECTLY INVOLVED IN THE INCIDENT AND NOT ABLE TO MEET ITS SPECIFICATIONS. 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 · 1

    USER REPORTS SYSTEM OVERHEATING. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902968 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW

    Patients

    Seq Age Sex Outcome Treatment
    1