BEUDAMED
    FDA Adverse Event Other Summary report: N

    S3 ROLLER PUMP

    MDR report key: 2253445 · Received September 9, 2011

    Report

    Report Number
    1718850-2011-00103
    Event Type
    Other
    Date Received
    September 9, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 12, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MFRS THE S3 ROLLER PUMP. THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE ARTERIAL PUMP STOPPED DURING A CASE. THE CUSTOMER REPORTED THAT AN ERROR CODE WAS DISPLAYED, BUT COULD NOT RECALL THE ACTUAL CODE. THE PUMP WAS HAND CRANKED TO MAINTAIN BLOOD FLOW. THE PUMP WAS CHANGED OUT. AFTER THE CASE, THE USER TESTED THE PUMP AND WAS UNABLE TO REPRODUCE THE FAILURE. A SORIN GROUP SERVICE ENGINEER WAS AT THE FACILITY TO EVALUATE THE PUMP AND ALSO FOUND THAT IT PERFORMED AS EXPECTED. SORIN GROUP (B)(4) HAS REQUESTED THAT THE PUMP BE RETURNED FOR EVAL. 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 ARTERIAL PUMP STOPPED DURING A CASE. THE CUSTOMER REPORTED THAT AN ERROR CODE WAS DISPLAYED, BUT COULD NOT RECALL THE ACTUAL CODE. THE PUMP WAS HAND CRANKED TO MAINTAIN BLOOD FLOW. THE PUMP WAS CHANGED OUT.

    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 68 YR