BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOCKERT S3 ROLLER PUMP MODULE STOCKERT SE CONSOLE

    MDR report key: 3902395 · Received June 24, 2014

    Report

    Report Number
    1718850-2014-00189
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 28, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K950990
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S3 ROLLER PUMP MODULE AND CONSOLE. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE SE ROLLER PUMP SHUTDOWN INSTEAD OF SWITCHING TO BATTERY POWER WHEN IT WAS UNPLUGGED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. 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 S3 ROLLER PUMP SHUTDOWN INSTEAD OF SWITCHING TO BATTERY POWER WHEN IT WAS UNPLUGGED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. 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 AN OPEN SHUNT RESISTOR IN THE E/P PACK. THE RESISTOR WAS REPLACED AND SUBSEQUENT TESTING CONFIRMED THAT EVERYTHING WAS FUNCTIONING PROPERLY. THE SERVICE REPRESENTATIVE ALSO COMPLETED AN ELECTRICAL SAFETY TEST AND THE CUSTOMER WAS INFORMED THAT A BATTERY TEST SHOULD BE PERFORMED IN ACCORDANCE WITH THE OPERATOR'S MANUAL AS SOON AS POSSIBLE. 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 DEUTSCHLAND WILL CONTINUE TO MONITOR THE MARKET FOR TRENDS.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE S3 ROLLER PUMP SHUTDOWN INSTEAD OF SWITCHING TO BATTERY POWER WHEN IT WAS UNPLUGGED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368401 STOCKERT S3 ROLLER PUMP MODULE STOCKERT SE CONSOLE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 43-40-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA