BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 10442565 · Received August 24, 2020

    Report

    Report Number
    8010762-2020-00272
    Event Type
    Malfunction
    Date Received
    August 24, 2020
    Date of Event
    August 16, 2020
    Report Date
    October 28, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL FAILURE DESCRIPTION WAS "HEAD ERROR". THE DEFECT ROTAFLOW DRIVE HAS BEEN REQUESTED UNDER THE RMA#41888 FOR FURTHER INVESTIGATIONS. 2020-09-02: DRIVE RECEIVED. 2020-09-28: FUNCTION TESTS IN THE SERVICE DEPARTMENT RASTATT: FAILURE COULD NOT BE CONFIRMED AS THE CLOSING ASSY WAS MISSING. 2020-10-26: DRIVE SEND TO EMTEC FOR REPAIR. 2020-10-28: SERVICE REPORT RMA2020-1034 RECEIVED. 2020-10-28: FUNCTION TEST IN THE SERVICE DEPARTMENT RASTATT: ALL TESTS WERE PASSED. ACCORDING TO THE SERVICE REPORT 20200817 DATED ON 2020-08-17 THE ROTAFLOW DRIVE HAS BEEN CHECKED. THE DRIVE DISPLAYS THE ERROR MESSAGE "HEAD ERROR". ACCORDING TO THE SERVICE REPORT RMA2020-1034 DATED ON 2020-10-19 THE "HEAD ERROR" COULD BE CONFIRMED. THE MC1 AND MC 2 HAVE BEEN REPLACED. THE CLOSING ASSY HAS BEEN RENEWED. THE PRESSURE PIECE ON THE MAST HOLDER HAS BEEN MOUNTED AGAIN. THE ROTAFLOW DRIVE WAS TESTED. ALL TESTS WERE PASSED. MOST POSSIBLE ROOT CAUSE COULD BE DETERMINED AS: MISHANDLING ACCORDING TO THE SERVICE REPORT 10478546 DATED ON 2020-10-28 THE ROTAFLOW DRIVE HAS BEEN TESTED AS PER SERVICE PROTOCOL. ALL TESTS WERE PASSED. FURTHERMORE, THE INSTRUCTIONS FOR USE OF THE ROTAFLOW SYSTEM, SEE ROTAFLOW SYSTEM USER MANUEL, INSTRUCTIONS FOR USE / 4.2 / EN / 13, CHAPTER 8.1.2 CONTAIN DETAILED DESCRIPTIONS TO PREVENT AN ¿ERROR HEAD¿. THE REPORTED FAILURE "HEAD ERROR" WAS DISCOVERED DURING STARTUP OF THE ROTAFLOW. THE DEVICE WAS DIRECTLY INVOLVED IN THE EVENT 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 · 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

    ERROR HEAD AFTER CROSSING 1000 RPM FOUND ROTAFLOW DRIVE WAS DEFECTIVE. COMPLAINT ID:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909084 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW

    Patients

    Seq Age Sex Outcome Treatment
    1