BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP SYSTEM

    MDR report key: 8523908 · Received April 17, 2019

    Report

    Report Number
    8010762-2019-00101
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Date of Event
    March 29, 2019
    Report Date
    December 10, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ALL CORRECTIVE ACTIONS WILL BE HANDLED UNDER THE NC# (B)(4). THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPUMONARY¿S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.

    Additional Manufacturer Narrative · 0

    A SERVICE ORDER WAS NOT SENT TO THE DESIGNATED COMPLAINT UNIT (DCU), BUT IT WAS CONFIRMED THAT THE FLOW MEASUREMENT BOARD (FMB) WAS REPLACED. PROBABLE CAUSES COULD BE DETERMINED BY INVESTIGATIONS BY LIFE CYCLE ENGINEERING (LCE) OF IDENTICAL FMB¿S IN OTHER COMPLAINTS. ACCORDING TO INVESTIGATION REPORT LCE 2827 (INVESTIGATION PERFORMED ON 2015-11-18, REFER TO COMPLAINT (B)(4)) THE CAPACITOR C2 HAD A SHORT CIRCUIT. DUE TO THAT THE ¿-12 V FAILURE¿ APPEARED AND THE FUSE F1 WAS TRIGGERED. ACCORDING TO LCE 3852 (INVESTIGATION PERFORMED ON 2018-07-12, REFER TO TRACKWISE (B)(4)) THE FMB WAS DAMAGED BY A SERVICE TECHNICIAN. WHEN REMOVING IT THE SOLDERING JOINT OF POTENTIOMETER POT3 WAS BROKEN. OTHER MALFUNCTIONS OF THE FMB, THE ROTAFLOW DRIVE OR WIRES WOULD LEAD TO THE ERROR MESSAGES ¿----¿OR ¿-**-¿ ON THE FLOW DISPLAY. THUS OTHER COMPONENTS CAN BE EXCLUDED AS PROBABLE ROOT CAUSE. THE FAILURE COULD BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    MAQUET MEDICAL SYSTEMS,USA(IMPORTER)SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). REFERENCE EXEMPTION # E2018002.

    Description of Event or Problem · 0

    INTERNAL REFERENCE #: (B)(4). AUTONUMBER: (B)(4).

    Description of Event or Problem · 0

    INTERNAL REFERENCE #: (B)(4). AUTONUMBER: 19-0278.

    Description of Event or Problem · 0

    (B)(4). DURING USE ON THE PATIENT THE ERROR MESSAGE "TXRX ERROR" WAS DISPLAYED AND THE PUMP STOPPED. THE DEVICE WAS EXCHANGED ONE WHILE USING THE HAND CRANK. NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317091 ROTAFLOW CENTRIFUGAL PUMP SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH ROTAFLOW CONSOLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention