BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 ROLLER PUMP

    MDR report key: 2253190 · Received September 7, 2011

    Report

    Report Number
    1718850-2011-00099
    Event Type
    Other
    Date Received
    September 7, 2011
    Date of Event
    June 28, 2011
    Report Date
    August 8, 2011
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE DATE WILL BE PROVIDED IN A F/U REPORT WHEN AVAILABLE. SORIN GROUP (B)(4) MANUFACTURES THE S5 ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE SORIN ENGINEER CHECKED THE PUMP BUT COULD NOT REPRODUCE THE PROBLEM. SORIN GROUP (B)(4) HAS REQUESTED THAT THE PUMP BE RETURNED FOR EVAL. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. THE FACILITY REPORTED THE INCIDENT TO THE COUNTRY'S COMPETENT AUTHORITY. THIS MEDWATCH REPORT IS BEING FILED DUE TO THIS ACTION.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT DURING THE PROCEDURE, THE VENT PUMP DISPLAYED AN ERROR CODE 432. THE MEDICAL ENGINEER POWER CYCLED THE PUMP BUT THE ERROR CODE REMAINED. THE PUMP WAS CHANGED OUT. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-80-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1