BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE

    MDR report key: 3213260 · Received July 1, 2013

    Report

    Report Number
    1718850-2013-00103
    Event Type
    Other
    Date Received
    July 1, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 4, 2013
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K950990
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO NOT PROVIDED. SORIN GROUP (B)(4) MANUFACTURES THE STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE S3 ROLLER PUMP STOPPED WHEN THE USER CHANGED THE FLOW RATE SETTING FOR THE CARDIOPLEGIA DURING THE PROCEDURE. THE PUMP WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. THERE WAS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297703 STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 43-40-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP