BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT S3 GAS BLENDER

    MDR report key: 4392229 · Received December 22, 2014

    Report

    Report Number
    1718850-2014-00477
    Event Type
    Other
    Date Received
    December 22, 2014
    Date of Event
    November 22, 2014
    Report Date
    November 26, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S3 GAS BLENDER. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE S3 GAS BLENDER IS NOT SOLD IN THE UNITED STATES BUT IT IS SIMILAR TO THE S5 GAS BLENDER WHICH IS SOLD IN THE UNITED STATES. THE 510K NUMBER FOR THE S5 GAS BLENDER IS K101046. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4) MANUFACTURES THE S3 GAS BLENDER. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE S3 GAS BLENDER ALARMED AND LOST FUNCTION DURING A PROCEDURE. IT ALARMS AND ALL DIGITAL DISPLAYS FLASH. WHEN TESTED ON ANOTHER MACHINE, AN ERROR MESSAGE DISPLAYED. THE ISSUE WAS CONFIRMED. THE CAUSE WAS A DEFECTIVE FRONT PANEL. THE PANEL WAS REPLACED AND THE UNIT WAS TESTED WITHOUT ANY PROBLEMS. NO NONCONFORMITIES WERE NOTED DURING MANUFACTURING RECORD REVIEW. THE ISSUE WILL BE MONITORED FOR TRENDS AND IF IDENTIFIED, CORRECTIONS WILL BE RECOMMENDED.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE S3 GAS BLENDER ALARMED AND LOST FUNCTION DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843138 STOCKERT S3 GAS BLENDER GAS CONTROL UNIT, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 25-40-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1