BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP SYSTEM

    MDR report key: 4285714 · Received December 1, 2014

    Report

    Report Number
    8010762-2014-00706
    Event Type
    Injury
    Date Received
    December 1, 2014
    Date of Event
    April 20, 2013
    Report Date
    April 20, 2013
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE METHODIST BIOMED TECHNICIAN HAS NOT BEEN ABLE TO REPRODUCE THE ISSUE DESPITE SEVERAL ATTEMPTS. THE METHODIST BIOMED WILL BE CHANGING OUT THE CHARGING BOARD AND REQUESTED THE MAQUET SSU TO EXAMINE THE CIRCUIT BOARD THAT WILL BE REPLACED. ON (B)(4) 2013, SERVICE ORDER NO. (B)(4) WAS GENERATED FOR THIS ROTAFLOW UNIT. PER THE SERVICE ORDER, A COMPLETE PREVENTIVE MAINTENANCE WAS PERFORMED ON THE UNIT. REFERENCE: COMPLAINT (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE MAQUET SALES AND SERVICE UNIT (SSU) WAS INFORMED THAT ROTAFLOW CONSOLE (RFC) WITH SERIAL NUMBER (B)(4), AT METHODIST HOSPITAL,LOST POWER. ACCORDING TO THE CUSTOMER, THE UNIT WAS UNPLUGGED TO TRANSPORT PATIENT AND THE RFC LOST ALL BATTERY POWER WITHIN 30 SECONDS AFTER BEING UNPLUGGED. THE AC LIGHT WAS ON BEFORE THE UNIT WAS UNPLUGGED. THE PATIENT WAS SWITCHED TO A NEW RFC AS A RESULT OF THIS INCIDENT. REFERENCE: COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774115 ROTAFLOW CENTRIFUGAL PUMP SYSTEM PUMP, BLOOD, CARDIOPULMONARY BYPASS KFM MAQUET CARDIOPULMONARY AG 70104.3292

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention