BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 GAS BLENDER SYSTEM

    MDR report key: 3912331 · Received June 27, 2014

    Report

    Report Number
    1718850-2014-00212
    Event Type
    Other
    Date Received
    June 27, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K101046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 GAS BLENDER SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT THE S5 GAS BLENDER DID NOT HOLD A SET FLOW RATE. THERE WAS NO REPORT OF PATIENT INJURY. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE S5 GAS BLENDER DID NOT HOLD A SET FLOW RATE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376472 S5 GAS BLENDER SYSTEM GAS CONTROL UNIT, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 25-40-45 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP