BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 9612494 · Received January 21, 2020

    Report

    Report Number
    8010762-2020-00028
    Event Type
    Malfunction
    Date Received
    January 21, 2020
    Report Date
    May 7, 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 · 0

    ROTAFLOW DRIVE AND CONSOLE WAS SENT BACK UNDER RMA# (B)(4) TO RASTATT. INCOMING GOODS IN RASTATT 2020-02-25. ROTAFLOW CONSOLE CHECKED AND REPAIRED BY SERVICE IN RASTATT ON 2020-03-13. ROTAFLOW DRIVE SENT TO EMTEC 2020-03-19. BACK FROM EMTEC 2020-05-05. FUNCTIONALTEST AFTER EMTEC 2020-05-06 DURING FUNCTIONALTEST IT WAS NOTICED THAT THE BATTERY INDICATOR DOESN´T WORK. THE 70103.4016 RFC DISPLAY BOARD WAS ADDITIONAL REPLACED ON THE ROTAFLOW CONSOLE, AFTER THE REPLACEMENT THE CONSOLE AND DRIVE PASSED ALL TESTS. ACCORDING TO THE SERVICE REPORT 10478103 DATED ON 2020-05-07 THE ROTA FLOW CONSOLE WAS REPAIRED BY THE SERVICE IN RASTATT AND THE FLOW MEASUREMENT BOARD (70101.1681) AND 70103.4016 RFC DISPLAY BOARD WAS REPLACED. ADDITIONAL THE 70107.3413 RF COVER FOR D-SUB PLUG WAS ALSO REPLACED. THE DRIVE WAS INVESTIGATED UNDER RMA2020-10066 DATED ON 2020-04-24 BY THE MANUFACTUER EMTEC. THE REPORTED "TXRX ERROR" COULD NOT REPRODUCED. IT WAS DETECTED THAT OIL IN THE MASTHOLDER IS MISSING. OIL WAS FILLED IN THE MASTHOLDER. DRIVE PASSED ALL TEST. THE REPORTED "TXRX ERROR" OCCURRED ON THE ROTAFLOW AND NOT ON THE ROTAFLOW DRIVE. THE REPORTED FAILURE "TXRX" ERROR IS ALREADY INVESTIGATED 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#705005555) 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 REPORTED "TXRX ERROR" COULD BE CONFIRMED ON THE ROTAFLOW CONSOLE. 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 IS DISPLAYED ON THE ROTAFLOW CONSOLE. WHEN THE ERROR MESSAGE OCCURRED ITS UNKNOWN TILL NOW. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73567 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH 70101.0874 - RFC 20-970 ROTAFLOW CONSOLE

    Patients

    Seq Age Sex Outcome Treatment
    1