BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 12266494 · Received August 3, 2021

    Report

    Report Number
    8010762-2021-00424
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    July 25, 2021
    Report Date
    November 25, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 "HEAD ERROR" DURING PATIENT TREATMENT. THE DEVICE HAS BEEN RESTARTED TO SOLVE THE REPORTED FAILURE. NO PATIENT HARM HAS OCCURRED. A GETINGE SERVICE TECHNICIAN WAS ON SITE ON 2021-08-23 TO CHECK THE AFFECTED ROTAFLOW CONSOLES (SERIAL#(B)(6)) AND ROTAFLOW DRIVE (SERIAL#(B)(6)). THE TECHNICIAN WAS UNABLE TO REPRODUCE THE REPORTED FAILURE. AS A PRECAUTION THE RF CONTROL BOARD PCBA KIT (MATERIAL#701034051) ON ALL THREE OF THE AFFECTED CONSOLES HAVE BEEN REPLACED. THE ROTAFLOWS ARE WORKING AS INTENDED. THE AFFECTED RF CONTROL BOARD PCBA KIT (SERIAL#(B)(6)) WERE SENT BACK TO MANUFACTURER FOR FURTHER INVESTIGATION. ON 2021-11-11 THE LIFE-CYCLE-ENGINEERING (LCE) WAS ABLE TO REPRODUCE THE REPORTED FAILURE "HEAD ERROR". THE MOST PROBABLE ROOT CAUSE COULD BE DETERMINED AS A DEFECTIVE COMMUNICATION LINE DRIVER IC22 ON THE CONTROL BOARD PCBA. THE INCOMING SIGNAL FROM THE RFD (ROTAFLOW DRIVE) IS NOT TRANSFERRED TO THE PROCESSOR OF THE CONTROLLER BOARD. AS COMMUNICATION TO THE RFD IS NOT POSSIBLE, THE MESSAGE ¿ERROR HEAD¿ IS DISPLAYED AND THE SYSTEM IS NOT RELEASED FOR OPERATION. BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURE COULD BE CONFIRMED. A DEVICE HISTORY REVIEW (DHR) WAS PERFORMED ON 2021-11-25 AND THE DHR DOES NOT SHOW ANY ABNORMALITY OR ISSUE THAT IS RELATED OR COULD HAVE LED TO THE CUSTOMER COMPLAINT. 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. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE ROTAFLOW DEVICES ((B)(4)) DISPLAYED THE ERROR MESSAGE ¿HEAD ERROR¿ DURING PATIENT TREATMENT. THE DEVICE HAS BEEN RESTARTED TO SOLVE THE REPORTED FAILURE. THE FIELD SERVICE TECHNICIAN COULD NOT REPRODUCE THE REPORTED FAILURE. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166474 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention