BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 10057040 · Received May 14, 2020

    Report

    Report Number
    8010762-2020-00163
    Event Type
    Malfunction
    Date Received
    May 14, 2020
    Date of Event
    May 8, 2020
    Report Date
    May 14, 2020
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FAILURE "TXRX ERROR" WAS NOTICED BY A GETINGE SERVICE TECHNICIAN IN THE REPAIR CENTER. ACCORDING TO THE SERVICE REPORT 43337624 DATED ON THE 2020-05-08 A GETINGE SERVICE TECHNICIAN CONFIRMED THE ERROR MESSAGE "TXRX ERROR". THE 70101.1681 FLOW MEASURE BOARD HAS BEEN REPLACED DUE TO TWO BAD SOLDER JOINTS ON TWO SEPARATE POTENTIOMETERS. THE ROTAFLOW WAS TESTED AFTER FACTORY SPECIFICATIONS AND PASSED ALL TESTS SUCCESSFULLY. 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 (B)(6) 2015, 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 (B)(6) 2018, 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 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

    THE TECHNICIAN FOUND THE "TXRX ERR" WHILE INSPECTING THE ROTAFLOW IN THE REPAIR CENTER. NO PATIENT INVOLVED. FLOW MEASURE BOARD HAS BEEN REPLACED AND TESTED PER SERVICE MANUAL. ALL TESTS PASSED. COMPLAIN ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519015 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM 701043292 - ROTAFLOW ENGLISH/US US-PLUG

    Patients

    Seq Age Sex Outcome Treatment
    1