BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT ROLLER PUMP MODULE 10-10-00

    MDR report key: 23253 · Received March 27, 1995

    Report

    Report Number
    2022323-1995-00001
    Event Type
    Injury
    Date Received
    March 27, 1995
    Date of Event
    March 6, 1995
    Report Date
    March 23, 1995
    Manufacturer
    STOCKERT INSTRUMENTE GMBH
    Product Code
    DWB
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PUMP WAS FOUND STOPPED AFTER THE PT'S HEART RATE MONITOR ALARMED. NEITHER THE ECMO ALARM SILENCE OR OVERRIDE WERE ENGAGED. THEREFORE, MACHINE/ALARM FAILURE IS QUESTIONED. PT UNSTABLE OFF PUMP AND CONDITION DETERATING WHEN FOUND BUT EXPERIENCED NO SEQUELAE. THE CAUSE OF THE MACHINE/ALARM FAILURE IS UNVERIFIED AFTER COMPLETE ASSESSMENT BY SORIN BIOMEDICAL, INC. FIELD SERVICE TECHNICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STOCKERT ROLLER PUMP MODULE 10-10-00 ROLLER PUMP DWB STOCKERT INSTRUMENTE GMBH 10-10-00 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Required Intervention