BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 1723661 · Received June 9, 2010

    Report

    Report Number
    1828100-2010-00509
    Event Type
    Malfunction
    Date Received
    June 9, 2010
    Date of Event
    May 13, 2010
    Report Date
    June 9, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    JOR
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE ROLLER PUMP WAS MAKING A NOISE. AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED THE NOISE PROBLEM WAS DISCOVERED DURING THE PRE-SET UP EQUIPMENT CHECK, AND THERE WERE NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 ROLLER PUMP JOR TERUMO CARDIOVASCULAR SYSTEMS CORP. 16402

    Patients

    Seq Age Sex Outcome Treatment
    1