BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN BIOMEDICAL INC.

    MDR report key: 10174 · Received August 25, 1993

    Report

    Report Number
    10174
    Event Type
    Malfunction
    Date Received
    August 25, 1993
    Date of Event
    August 16, 1993
    Report Date
    August 18, 1993
    Manufacturer
    SORIN BIOMEDICAL, INC.
    Product Code
    DWB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 8/16/93 A PHYSICIAN WAS PERFORMING CORONARY ARTERY BYPASS WHEN HE NOTICED THAT THERE WAS NO FLOW IN INTERNAL MAMMARY ARTERY. AFTER CLOSER OBSERVATION IT WAS NOTED THAT THERE WAS AIR IN THE ARTERIOCANNULA. THERE WAS NO ARTERIAL BLOOD FLOW AND THE CAPS PUMP #1 HAD STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SORIN BIOMEDICAL INC. CAPS CONSOLE BASE DWB SORIN BIOMEDICAL, INC. 41-50-50

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other