BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 12778497 · Received November 9, 2021

    Report

    Report Number
    8010762-2021-00594
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 31, 2021
    Report Date
    February 14, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 THE US. IT WAS REPORTED THAT THE ERROR MESSAGE ¿REFERNC ERROR¿ OCCURRED DURING PATIENT USE ON THE ROTAFLOW CONSOLE (RFC). THE MEDICAL STAFF BEGAN HAND CRANKING IMMEDIATELY. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE ROTAFLOW CONSOLE (RFC) WITH S/N (B)(6) WAS INVESTIGATED BY A GETINGE FIELD SERVICE TECHNICIAN AND THE TECHNICIAN WAS ABLE TO CONFIRM THE REPORTED FAILURE "REFERENC ERROR". THE RFC (ROTAFLOW CONSOLE) POWER SUPPLY BOARD (ARTICLE NUMBER 701011675) HAS BEEN REPLACED. PREVENTIVELY THE RFC FLOW MEASURE BOARD (ARTICLE NUMBER 701011681) AND THE RFC CONTROL BOARD (ARTICLE NUMBER 701034051) HAS BEEN ALSO REPLACED. THE DEVICE WAS TESTED AND IS BACK IN USE. THE REPORTED FAILURE "REFERENC ERROR" WAS ALREADY INVESTIGATED BY THE GETINGE LIFE CYCLE ENGINEERING AND DETERMINED THE ROOT CAUSE AS A PARTIAL BREAKTHROUGH ON THE CAPACITOR C109 ON POWER SUPPLY 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 2021-11-09 DURING THE PERIOD OF 2007-11-01 TO 2021-11-09 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 PRODUCT IN QUESTION WAS PRODUCED IN 2007-11-01. 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

    THE EVENT OCCURRED IN THE US. IT WAS REPORTED THAT THE ERROR MESSAGE ¿REFERENC ERROR¿ OCCURRED DURING PATIENT USE ON THE ROTAFLOW CONSOLE. (RFC). CUSTOMER REPORTED RFC WAS ON A POWER STRIP WITH ANOTHER DEVICE AND BOTH DEVICES SHUT DOWN AT SAME TIME. MEDICAL STAFF BEGAN HAND CRANKING IMMEDIATELY. NO INDICATION OF ACTUAL OR POTENTIAL FOR HARM OR DEATH 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
    1679721 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH MCP00703159#RFC 20-970 ROTAFLOW CONSOLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown