BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI Q SVO2/CCO CATHETER

    MDR report key: 1913561 · Received November 30, 2010

    Report

    Report Number
    1913561
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 30, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    DQE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UNABLE TO GET INTO RIGHT VENTRICLE; TRANSIENT ASYSTOLE====================== HEALTH PROFESSIONAL'S IMPRESSION======================SAME AS ABOVE====================== MANUFACTURER RESPONSE FOR OPTI Q SVO2/CCO CATHETER, OPTI Q SVO2/CCO CATHETER======================WE HAD MANY DISCUSSIONS WITH THE MANUFACTURE'S REPRESENTATIVE. WE FOLLOWED THEIR RECOMMENDATIONS AND WE CONTINUE TO HAVE PRODUCT MALFUNCTIONS. THIS INTERFERES WITH PATIENT CARE.======================IN A PHONE CONVERSATION THE REPORTER INDICATED THE DEVICE LOT NUMBER FOR REPORT NUMBER 12 IS 88-103-2A. THE LOT NUMBER FOR THE DEVICES ON THE OTHER SIX REPORTS MAY BE DIFFERENT. A NEW DEVICE WAS IMPLANTED ON THE PATIENTS LISTED ON REPORTS 12, 15, 16, AND 17. WHILE ON REPORTS 13 AND 14 THEY RESOLVED THE ISSUE AND IMPLANTED THE SAME DEVICE. ON REPORT NUMBER 11 THE DEVICES WERE NOT REMOVED FROM THE PATIENTS. THEY MONITORED THE PATIENTS CLOSELY. REPORTER INDICATED THERE WAS NO VISIBLE MANUFACTURER PROBLEM NOTICED ON THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI Q SVO2/CCO CATHETER OPTI Q SVO2/CCO CATHETER DQE HOSPIRA, INC. LIST NO. 52511-13 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *