BEUDAMED
    FDA Adverse Event Other Summary report: N

    S3 ROLLER PUMP

    MDR report key: 4202637 · Received October 16, 2014

    Report

    Report Number
    1718850-2014-00380
    Event Type
    Other
    Date Received
    October 16, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WAS NOT PROVIDED. SORIN GROUP (B)(4) MFRS THE S3 ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) 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 RECEIVED A REPORT THAT THE S3 ROLLER PUMP WOULD STUTTER BETWEEN CERTAIN PUMP SPEEDS DURING A PROCEDURE. A SORIN REPRESENTATIVE REPRODUCED THE ISSUE. HE REPLACED THE POTENTIOMETER AND THE FRONT PANEL. MULTIPLE TESTS WERE RUN WITH NO FURTHER ERRORS. NO OTHER PROBLEMS HAVE BEEN REPORTED. NO TRENDS HAVE BEEN IDENTIFIED. NO FURTHER INVESTIGATION IS REQUIRED. NO NONCONFORMITIES WERE NOTED DURING MANUFACTURING RECORD REVIEW. THE ISSUE WILL BE MONITORED FOR TRENDS AND IF IDENTIFIED, CORRECTIONS WILL BE RECOMMENDED.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE S3 ROLLER PUMP WOULD STUTTER BETWEEN CERTAIN PUMP SPEEDS DURING A PROCEDURE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659767 S3 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-60-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP