BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 GAS BLENDER

    MDR report key: 3644496 · Received December 17, 2013

    Report

    Report Number
    1718850-2013-00305
    Event Type
    Other
    Date Received
    December 17, 2013
    Date of Event
    November 15, 2013
    Report Date
    November 22, 2013
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTX
    PMA / PMN Number
    K101046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. SORIN GROUP (B)(4) MANUFACTURES THE S5 GAS BLENDER. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE S5 GAS BLENDER WAS DISPLAYING AN E15 ERROR DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660326 S5 GAS BLENDER GAS CONTROL UNIT, CARDIOPULMONARY BYPASS DTX SORIN GROUP DEUTSCHLAND 25-40-45 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA