BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 10013897 · Received April 30, 2020

    Report

    Report Number
    8010762-2020-00147
    Event Type
    Malfunction
    Date Received
    April 30, 2020
    Date of Event
    April 24, 2020
    Report Date
    May 6, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE "TXRX ERROR" OCCURRED BEFORE USING THE DEVICE. ACCORDING TO THE COMMUNICATION GRID IN THE COMPLAINT DATED ON 2020-05-05 THE FLOW MEASUREMENT BOARD (701011681) HAS BEEN REPLACED. THE REPORTED FAILURE IS ALREADY KNOWN AND INVESTIGATED IN OUR LIFE CYCLE ENGINEERING WITH THE FOLLOWING RESULT: 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 INTERNAL SHORT CIRCUIT IN THE CAPACITOR C2. THE "TXRX ERROR" OCCURRED BEFORE USING THE DEVICE AND COULD BE CONFIRMED. 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

    A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A CUSTOMER FROM (B)(6) THAT ERROR TXRX OCCURRED AFTER THIS ROTAFLOW WAS SWITCHED ON. THE FLOW MEASURE BOARD WAS BROKEN. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477370 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH 701046405 - ROTAFLOW CHINESE ZH-PLUG

    Patients

    Seq Age Sex Outcome Treatment
    1