BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN S3 BUBBLE DETECTOR SENSOR

    MDR report key: 6149886 · Received December 6, 2016

    Report

    Report Number
    9611109-2016-00808
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Date of Event
    November 10, 2016
    Report Date
    November 10, 2016
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    KRL
    PMA / PMN Number
    K955152
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. SORIN GROUP (B)(4) MANUFACTURES THE SORIN S3 BUBBLE DETECTOR SENSOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE CONFIRMED THE REPORTED ISSUE AND REPLACED THE BUBBLE SENSOR. SUBSEQUENT TESTING DID NOT IDENTIFY FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. 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 AN ERROR MESSAGE WAS DISPLAYED ON THE HEART-LUNCH MACHINE REGARDING THE SORIN S3 BUBBLE DETECTOR SENSOR DURING A PROCEDURE. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799012 SORIN S3 BUBBLE DETECTOR SENSOR MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS KRL SORIN GROUP DEUTSCHLAND 23-07-40

    Patients

    Seq Age Sex Outcome Treatment
    1