BEUDAMED
    FDA Adverse Event Summary report: N

    S3 ROLLER PUMP

    MDR report key: 1823076 · Received August 6, 2010

    Report

    Report Number
    1823076
    Date Received
    August 6, 2010
    Date of Event
    June 30, 2009
    Report Date
    September 4, 2009
    Manufacturer
    STOCKERT/SORIN
    Product Code
    DWB
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ECMO ROLLER PUMP HAD AN AIR BUBBLE ALARM WHICH STOPPED THE PUMP. THE PERFUSIONIST WAS HAND CRANKING THE ROLLER PUMP AND TRYING TO START THE MACHINE UP BUT AN ERROR CODE WAS PRODUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S3 ROLLER PUMP PUMP, CARDIOPULMONARY BYPASS,ROLLER PUMP DWB STOCKERT/SORIN 10-60-00 *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 DAY