BEUDAMED
    FDA Adverse Event Other Summary report: N

    S3 ROLLER PUMP

    MDR report key: 2132734 · Received June 2, 2011

    Report

    Report Number
    1718850-2011-00047
    Event Type
    Other
    Date Received
    June 2, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 3, 2011
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K950990
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP DEUTSCHLAND MANUFACTURES THE S3 ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) HAS RECEIVED THE PRODUCT FOR EVAL AND IS CONDUCTING AN INVESTIGATION. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. THERE WAS NO REPORT OF PT INJURY. THE FACILITY HAS FILED A REPORT WITH THE COUNTRY'S COMPETENT AUTHORITY. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS ACTION.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, AN ERROR CODE OCCURRED AND THE PUMP STOPPED. THE PUMP WAS POWER CYCLED AND RESTARTED. THE ERROR CODE APPEARED AGAIN AND THE PUMP WAS CHANGED OUT. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S3 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-60-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1