BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 12664030 · Received October 20, 2021

    Report

    Report Number
    8010762-2021-00563
    Event Type
    Malfunction
    Date Received
    October 20, 2021
    Date of Event
    October 18, 2021
    Report Date
    November 18, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT THE ERROR MESSAGE ¿REFERENC ERROR¿ OCCURRED WHEN THE ROTAFLOW CONSOLE WAS TURNED ON. THE DEVICE WAS NOT USED ON THE PATIENT. NO HARM HAS BEEN REPORTED. THE ROTAFLOW CONSOLE (RFC) WITH S/N (B)(6) WAS INVESTIGATED BY A GETINGE FIELD SERVICE TECHNICIAN ON 2021-11-04. THE TECHNICIAN COULD CONFIRMED THE REPORTED FAILURE "REFERENC ERROR" AND REPLACED THE RFC FLOW MEASURE BOARD (ARTICLE NUMBER 701011681). THE DEVICE WAS SENT BACK TO THE CUSTOMER. THE REPORTED FAILURE "REFERENC ERROR" WAS ALREADY INVESTIGATED BY THE GETINGE LIFE CYCLE ENGINEERING AND DETERMINED THE ROOT CAUSE A PARTIAL BREAKTHROUGH OF THE CAPACITOR C109 ON THE FLOW MEASUREMENT BOARD, WHICH OVERLOADS THE VOLTAGE CONVERTER. THIS LED TO THE REPORTED ERROR. BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE "REFERENC ERROR" COULD BE CONFIRMED. THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2021-11-18 DURING THE PERIOD OF 2019-03-01 TO 2021-11-18 DOES NOT SHOW ANY NON-CONFORMITY 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 ROTAFLOW CONSOLE IN QUESTION WAS PRODUCED IN 2019-03-01. 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

    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.

    Description of Event or Problem · 1

    THE EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE ERROR MESSAGE ¿REFERENCE ERROR¿ OCCURRED WHEN THE ROTAFLOW CONSOLE WAS TURNED ON. DEVICE WAS NOT USED ON THE PATIENT. NO INDICATION OF ACTUAL OR POTENTIAL FOR HARM OR DEATH HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566230 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH MCP00706291#ROTAFLOW PUMP MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown