BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 12540678 · Received September 28, 2021

    Report

    Report Number
    8010762-2021-00528
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Report Date
    November 11, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL FAILURE DESCRIPTION WAS THAT THE ROTAFLOW DISPLAYED THE ERROR MESSAGE "B TEMP". THE FAILURE OCCURRED DURING BEFORE USE. NO PATIENT HAS BEEN INVOLVED. A GETINGE SERVICE TECHNICIAN WAS ON SITE ON 2021-10-14 TO REPAIR THE AFFECTED ROTAFLOW (SERIAL# (B)(6)). THE TECHNICIAN CONFIRMED THE REPORTED FAILURE AND REPLACED THE BATTERY PACK WITH FUSE REPLACEMENT (MATERIAL#70101.7188). AFTER THE REPLACEMENT THE DEVICE IS WORKING AS INTENDED. AN INVESTIGATION OF A ROTAFLOW SYSTEM THAT EXHIBITED A SIMILAR ISSUE "B TEMP" WAS PERFORMED IN GETINGE LIFE CYCLE ENGINEERING ON 2019-12-09: THE MOST PROBABLE ROOT CAUSE OF THE PRESENTED ERROR IS A DISPLACED CONTACT DUE TO INCORRECT ASSEMBLY OF THE CONNECTOR ON THE BATTERY PACK. BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURE COULD BE CONFIRMED. THE PRODUCT IN QUESTION WAS PRODUCED IN 2005-09-02. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2021-11-11 FOR THE PERIOD OF 2005-09-02 TO 2021-09-17. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THERE IS NO INDICATION ON MANUFACTURING ISSUES OCCURRED DURING THIS TIME, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. 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. 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.

    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 THAT THE ROTAFLOW DISPLAYED THE ERROR MESSAGE ¿B TEMP ERROR¿ AFTER START UP OF THE DEVICE. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437397 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW CONSOLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown