BEUDAMED
    FDA Adverse Event Other Summary report: N

    TANDEMHEART

    MDR report key: 668106 · Received January 5, 2006

    Report

    Report Number
    668106
    Event Type
    Other
    Date Received
    January 5, 2006
    Date of Event
    November 7, 2005
    Report Date
    January 2, 2006
    Manufacturer
    CARDIACASSIST, INC
    Product Code
    DSQ
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PUMP WAS INDICATING FLOW RATES OF GREATER THAN 7.0 L/MINUTE WITH QUESTIONABLE BLOOD FLOW. THE PUMP WAS SWITCHED TO THE BACKUP CONTROLLER WITHOUT CHANGE IN INDICATED BLOOD FLOW. THE PUMP WAS RETURNED TO PRIMARY CONTROLLER WHICH THEN INDICATED LESS THAN 1.0 L/MINUTE BLOOD FLOW. THE COMPANY WAS CONTACTED FOR ADVICE. CANNULA WAS LEFT IN PLACE AND THE PUMP HEAD WAS CHANGED WITH RESULTANT BLOOD FLOW AT 4.0-4.5 L/MINUTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEMHEART LVAD DSQ CARDIACASSIST, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR