BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMEDICUS

    MDR report key: 35678 · Received August 15, 1996

    Report

    Report Number
    35678
    Event Type
    Injury
    Date Received
    August 15, 1996
    Date of Event
    August 5, 1996
    Report Date
    August 6, 1996
    Manufacturer
    MEDTRONIC BIO-MEDICUS, INC.
    Product Code
    HQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER ONE HOUR INTO OPEN-HEART SURGERY PROCEDURE, PERFUSIONIST NOTICED LARGE BOLUS OF AIR FROM VENOUS RESERVOIR TO PUMP HEAD. TUBING CLAMPED OFF, AIR ELIMINATED BUT WHEN TURNING PUMP BACK ON, IT FAILED TO START. REPLACED WITH SECOND PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMEDICUS PUMP HQY MEDTRONIC BIO-MEDICUS, INC. NONE NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening