BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTAFLOW ENGLISH/US ICU

    MDR report key: 3720021 · Received March 14, 2014

    Report

    Report Number
    3008355164-2014-00059
    Event Type
    Injury
    Date Received
    March 14, 2014
    Date of Event
    October 18, 2013
    Report Date
    October 21, 2013
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KFM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING SUPPORT OF A PATIENT WITH A ROTAFLOW CONSOLE, THE PERFUSIONIST RECEIVED A "SIG" ERROR MESSAGE. AFTER REAPPLICATION OF CONTACT CREAM, RPMS WERE NOT ABLE TO BE INCREASED AND A "HEAD ERROR" MESSAGE WAS DISPLAYED. THE CONSOLE WAS SHUT-DOWN AND RE-STARTED. IT WAS NOT IDENTIFIED THAT A ZEROING STEP WAS REQUIRED AND HAND CRANKING WAS USED UNTIL THE ZEROING AND SUCCESSFUL RESTART OCCURRED. AFTER RE-START, THE CONSOLE FUNCTIONED PROPERLY. ANOTHER PERFUSIONIST STATED THEY BELIEVED THIS WAS A USER-CREATED EVENT DURING REAPPLICATION OF THE CONTACT CREAM. NO REPORTED EFFECT TO THE PATIENT. THIS REPORT IS BEING SUBMITTED IN RESPONSE TO FDA INQUIRY (B)(4). PLEASE REFER MFR REPORT # 8010762-2014-00141.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152337 ROTAFLOW ENGLISH/US ICU ROTOFLOW PUMP KFM MAQUET CARDIOPULMONARY AG 701051712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention