BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT S3 CONSOLE

    MDR report key: 2298270 · Received October 6, 2011

    Report

    Report Number
    1718850-2011-00123
    Event Type
    Other
    Date Received
    October 6, 2011
    Date of Event
    August 7, 2011
    Report Date
    September 6, 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
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S3 CONSOLE. THE S3 ROLLER PUMP, SN (B)(4), IS A COMPONENT OF THE S3 SYSTEM. THE 510(K) NUMBER FOR THE S3 ROLLER PUMP IS K950990. THIS 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 PUMP SUDDENLY DISPLAYED ZERO. THE PUMP DID NOT STOP, HOWEVER THE FLOW DROPPED TO 1.8 LPM. THE DISPLAY AND FLOW REPORTEDLY WENT BACK TO NORMAL AFTER 1-2 SECONDS. THERE WAS NO REPORT OF PT INJURY AS A RESULT OF THIS INCIDENT. THE DISTRIBUTOR'S ENGINEER REPLACED THE SPEED POTENTIOMETER, DISCONNECTED AND RE-INSTALLED THE CIRCUIT BOARDS, THE RELOADED THE PUMP FROM POSITION 1 TO POSITION 3. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE PUMP SUDDENLY DISPLAYED ZERO. THE PUMP DID NOT STOP, HOWEVER THE FLOW DROPPED TO 1.8 LPM. THE DISPLAY AND FLOW REPORTEDLY WENT BACK TO NORMAL AFTER 1-2 SECONDS. THERE WAS NO REPORT OF PT INJURY AS A RESULT OF THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1