BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 GAS BLENDER

    MDR report key: 3818227 · Received May 13, 2014

    Report

    Report Number
    1718850-2014-00144
    Event Type
    Other
    Date Received
    May 13, 2014
    Report Date
    April 16, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTX
    PMA / PMN Number
    K101046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT 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 ON-GOING. 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 DISPLAYED AN ERROR DURING SET UP. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287452 S5 GAS BLENDER GAS CONTROL UNIT, CARDIOPULMONARY BYPASS DTX SORIN GROUP DEUTSCHLAND 25-40-45 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA