BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 SENSOR MODULE FOR BUBBLE DETECTION

    MDR report key: 5817525 · Received July 22, 2016

    Report

    Report Number
    9611109-2016-00458
    Event Type
    Malfunction
    Date Received
    July 22, 2016
    Date of Event
    June 27, 2016
    Report Date
    March 21, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTW
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. SORIN GROUP (B)(4) MANUFACTURES THE S5 SENSOR MODULE FOR BUBBLE DETECTION. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE S5 SENSOR MODULE FOR BUBBLE DETECTION DID NOT CONSISTENTLY ACTIVIATE AND SHUT OFF THE PUMP. THIS ISSUE WAS DISCOVERED BY A SORIN GROUP FIELD SERVICE REPRESENTATIVE DURING MAINTENANCE, SO THERE WAS NO PATIENT INVOLVEMENT. THE SERVICE REPRESENTATIVE TRIED CLEARING THE NVMEM, BUT THE ISSUE WAS NOT RESOLVED. THE SENSOR MODULE WAS REPLACED. THE UNIT WAS TESTED WITH THE NEW MODULE AND WAS FOUND TO BE WORKING CORRECTLY. NO FURTHER ISSUES WERE OBSERVED AND THE UNIT WAS RETURNED TO SERVICE. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    LIVANOVA (B)(4) MANUFACTURES THE S5 SENSOR MODULE FOR BUBBLE DETECTION. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE DEVICE WAS RETURNED TO SORIN GROUP USA, INC. FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES OR DEFECTS AND FUNCTIONAL TESTING WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. THE DEVICE WAS COLD-STARTED THREE TIMES AND RUN FOR 30 MINUTES WITHOUT ERROR. AS THE ISSUE COULD NOT BE REPRODUCED, A ROOT CAUSE WAS NOT DETERMINED AND CORRECTIVE ACTIONS WERE NOT IDENTIFIED. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. EVALUATED AT SORIN GROUP USA, INC.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE S5 SENSOR MODULE FOR BUBBLE DETECTION DID NOT CONSISTENTLY ACTIVIATE AND SHUT OFF THE PUMP. THIS ISSUE WAS DISCOVERED BY A SORIN GROUP FIELD SERVICE REPRESENTATIVE DURING MAINTENANCE, SO THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468397 S5 SENSOR MODULE FOR BUBBLE DETECTION CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTW SORIN GROUP DEUTSCHLAND 23-45-20

    Patients

    Seq Age Sex Outcome Treatment
    1