BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEART LUNG MACHINE

    MDR report key: 10815305 · Received November 10, 2020

    Report

    Report Number
    8010762-2020-00383
    Event Type
    Injury
    Date Received
    November 10, 2020
    Date of Event
    October 30, 2020
    Report Date
    January 4, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL FAILURE DESCRIPTION WAS THAT THE ROTAFLOW DISPLAYS THE ERROR MESSAGE DURING PATIENT TREATMENT. THE DEVICE HAS BEEN EXCHANGED WITH A BACKUP DEVICE. ACCORDING TO THE COMMUNICATION GRID DATED ON (B)(6) 2020 A GETINGE SERVICE TECHNICIAN CONFIRMS THAT THE AFFECTED ROTAFLOW NEEDS TO BE REPAIRED. THE 70101.1681 ROTAFLOW CONSOLE (RFC) FLOW MEASURE BOARD AND THE 70101.1675 RFC POWER SUPPLY BOARD ARE GOING TO BE REPLACED TO RESOLVE THE ERROR MESSAGE "REFERENCE". THE REPORTED FAILURE "REFERENCE" WAS ALREADY INVESTIGATED BY OUR LIFE-CYCLE-ENGINEERING (LCE) IN COMPLAINT (B)(4) IN THE LCE REPORT (B)(4). FOLLOWING MOST PROBABLE ROOT CAUSE COULD BE DETERMINED FOR THE FLOW MEASURE BOARD: THE CAPACITOR C109 HAS A PARTIAL BREAK-THROUGH WHICH OVERLOADS THE VOLTAGE CONVERTER, SO THAT FROM IT DERIVED VOLTAGES BECAME UNSTABLE. THE ROTAFLOW RISK ANALYSIS CHAPTER H1.1.1.3 VERSION V06 (DMS# (B)(4)) FOR THE POWER SUPPLY BOARD WAS REVIEWED ON 2020-12-29 WITH FOLLOWING OUTCOME: (UN)INTENTIONAL STOP OF THE PUMP, E.G.: DEFECTIVE MOTOR CONTROL ELECTRONICS. PUMP STOP INTERVENTION AFTER TECHNICAL ERROR (E.G. PUMP RUNAWAY, ERROR HEAD). SOFTWARE ERROR. THE PRODUCT IN QUESTION WAS PRODUCED IN 2018-03-14. THE REVIEW OF THE NON-CONFORMITIES DURING THE PERIOD OF 2018-03-14 TO 2020-12-29 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 CAN BE EXCLUDED. THE REPORTED FAILURE "REFERENCE" OCCURRED DURING PATIENT TREATMENT. THE DEVICE WAS DIRECTLY INVOLVED IN THE EVENT AND NOT ABLE TO MEET ITS SPECIFICATIONS. THE FAILURE COULD BE CONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    NEW INFORMATION RECEIVED ON 2020-11-12: THE PATIENT SUFFERED CARDIAC ARREST FOR SEVERAL SECONDS, THE VITAL SIGNS OF THE PATIENT GRADUALLY RECOVERED AND STABILIZED AFTER USING THE BACKUP DEVICE. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    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

    ERROR REFERENCE OCCURRED DURING TREATMENT. THE DEVICE HAS BEEN EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283983 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention