BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN S3 GAS BLENDER

    MDR report key: 4564630 · Received February 25, 2015

    Report

    Report Number
    9611109-2015-00037
    Event Type
    Malfunction
    Date Received
    February 25, 2015
    Date of Event
    January 30, 2015
    Report Date
    April 3, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) MANUFACTURES THE S3 GAS BLENDER. THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF (B)(4). A (B)(4) FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE LEARNED THAT THE USER COMPLETED THE PROCEDURE BY SWITCHING WITH O2 BOTTLE. THE SERVICE REPRESENTATIVE WAS ABLE TO REPRODUCE THE REPORTED ERROR. A LOANER UNIT WAS PROVIDED TO THE CUSTOMER AND THE FAULTY DEVICE WAS RETURNED TO (B)(4) FOR FURTHER INVESTIGATION. DURING EVALUATION AT (B)(4), THE ISSUE COULD NOT BE REPRODUCED. ALL TESTS PERFORMED WERE ERROR-FREE. A TEST RUN AND SAFETY CHECK WERE PERFORMED AND THE UNIT WAS RETURNED TO THE CUSTOMER. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    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 S5 GAS BLENDER IS NOT SOLD IN THE UNITED STATES BUT A SIMILAR S5 GAS BLENDER WHICH IS SOLD IN THE UNITED STATES. THE 510K # FOR THE S5 GAS BLENDER IS K101046. 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 S3 GAS BLENDER DISPLAYED AN ERROR MESSAGE DURING A PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134418 SORIN S3 GAS BLENDER GAS CONTROL UNIT, CARDIOPULMONARY BYPASS DTX SORIN GROUP DEUTSCHLAND 24-40-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP