BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT S5 SYSTEM

    MDR report key: 3982595 · Received July 22, 2014

    Report

    Report Number
    1718850-2014-00234
    Event Type
    Other
    Date Received
    July 22, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(6). SORIN GROUP RECEIVED A REPORT THAT THE S5 SYSTEM DISPLAYED AN ERROR DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE S5 SYSTEM DISPLAYED AN ERROR DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO INVESTIGATE. WHILE AT THE FACILITY THE SERVICE REPRESENTATIVE CONFIRMED THE REPORTED ISSUE AND FOUND THAT IT WAS CAUSED BY A PROBLEM WITH THE UPS-MODULE. THE UPS-MODULE WAS REPLACED AND SUBSEQUENT TESTING CONFIRMED THAT EVERYTHING WAS FUNCTIONING PROPERLY. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT FIND ANY DEVIATIONS OR NON-CONFORMITIES RELATED TO THE REPORTED ISSUE. THE SYSTEM WAS RETURNED TO SERVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR THE MARKET FOR TRENDS.

    Description of Event or Problem · 1

    SORIN GROUP (B)(6) RECEIVED A REPORT THAT THE STOCKERT S5 SYSTEM DISPLAYED AN ERROR DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429221 STOCKERT S5 SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 48-50-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1