BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 17327228 · Received July 14, 2023

    Report

    Report Number
    8010762-2023-00342
    Event Type
    Malfunction
    Date Received
    July 14, 2023
    Date of Event
    July 7, 2023
    Report Date
    November 27, 2023
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN FRANCE DURING BATTERY TESTING. IT WAS REPORTED THAT THE ROTAFLOW DISPLAYED THE "EEPROM" ERROR. THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT AFTERWARDS. NO HARM TO ANY PERSON HAS BEEN REPORTED. A GETINGE SERVICE TECHNICIAN INVESTIGATED THE ROTAFLOW CONSOLE WITH SERIAL NUMBER (B)(6). THE TECHNICIAN CONFIRMED THE REPORTED FAILURE AND REPLACED THE "RFC CONTROL BOARD KIT" (MATERIAL# 701034051). AFTER THE REPLACEMENT THE DEVICE IS WORKING AS INTENDED. A SIMILAR COMPLAINT (B)(4) WITH THE REPORTED FAILURE "EEPROM ERROR" HAS PREVIOUSLY BEEN INVESTIGATED BY GETINGE LIFE CYCLE ENGINEERING (LCE): THE MOST PROBABLE ROOT CAUSE COULD BE IDENTIFIED AS A READ-/WRITE-ERROR IN EEPROM BLOCK IC9, WHICH LED TO A COMPLETE FAILURE SINCE THE EEPROM WOULD NO LONGER PASS ITS SELF-TEST. THE MOST PROBABLE ROOT CAUSE FOR THE READ-/WRITE-ERROR IS STATISTICAL COMPONENT FAILURE. BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURE "EEPROM ERROR" COULD BE CONFIRMED. THE ROTAFLOW CONSOLE IN QUESTION WAS PRODUCED ON 2016-03-03. A REVIEW OF NON-CONFORMITIES WAS PERFORMED ON 2023-07-11, AND DURING THE TIME FROM 2016-03-03 TO 2023-07-11 THERE ARE NO NON-CONFORMITIES IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED DURING THIS TIME, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. 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

    THE EVENT OCCURRED IN FRANCE. IT WAS REPORTED THAT DURING BATTERY TESTING, THE ROTAFLOW CONSOLE (RFC) DISPLAYED THE ERROR MESSAGE ¿EEPROM¿. THE RFC WAS EXCHANGED FOR A BACKUP RFC. THE AFFECTED RFC WAS NOT USED FOR PATIENT TREATMENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    COMPLAINT ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805522 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH MCP00703167#RFC 20-970 ROTAFLOW CONSOLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other