BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 10057038 · Received May 14, 2020

    Report

    Report Number
    8010762-2020-00160
    Event Type
    Malfunction
    Date Received
    May 14, 2020
    Date of Event
    May 6, 2020
    Report Date
    July 21, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED FAILURE "NO MEASURING FLOW" WAS NOTICED BY THE ENGINEER. THE AFFECTED ROTAFLOW DRIVE WILL BE SENT BACK UNDER RMA#41036 FOR INVESTIGATION/REPAIR BY THE MANUFACTURER EMTEC. DRIVE RECEIVED IN RASTATT 2020-06-04 FUNCTIONALTEST IN RASTATT 2020-06-15: FAILURE CONFIRMED. SEND TO EMTEC 2020-06-18, BACK FROM EMTEC 2020-07-20, FUNCTIONALTEST AFTER EMTEC 2020-07-21. ACCORDING TO THE SERVICE REPORT RMA2020-10216 DATED ON 2020-07-09 THE REPORTED FAILURE "NO MEASURING FLOW" COULD BE REPRODUCED. THE SENSOR AMPLITUDE IS 0. ASSUMED THAT THE FLOWSENSOR IS DEFECTIVE, REPLACEMENT HAS NOT SOLVED THE PROBLEM. ROTAFLOW DRIVE CABLE DEFECTIVE. FOLLOWING WORK HAS BEEN DONE BY EMTEC. FLOW SENSOR REPLACED, ROTAFLOW DRIVE CABEL REPLACED, ROTAFLOW DRIVE PASSED ALL TESTS. THE MOST PROBABLE ROOT CAUSE COULD BE DETERMINED ACCORDING TO EMTEC AS AGING. ACCORDING TO THE SERVICE REPORT 10478363 DATED ON 2020-07-21 THE ROTAFLOW DRIVE WAS TESTED ACCORDING TO THE CURRENT SERVICE PROTOCOL. THE REPORTED FAILURE "NO MEASURING FLOW" WAS NOTICED BY THE ENGINEER 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 (B)(6) THAT A ROTAFLOW CONSOLE UNIT HAS A MALFUNCTION OF FLOW DISPLAY(LPM). THE ENGINEER FIGURED THE DEFECTIVE ROTAFLOW DRIVE UNIT OUT. DISASSEMBLED THE AFFECTED ROTAFLOW DRIVE AND CONNECTED TO ANOTHER RFC(REFERENCE UNIT) FOR A TEST. IN THE RESULT, THIS ROTAFLOW DRIVE INCURRED SAME PROBLEM ON BOTH OF RFC UNITS. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519012 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH 701022161- ROTAFLOW DRIVE UNIT, BLUE

    Patients

    Seq Age Sex Outcome Treatment
    1