BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARDIOPULMONARY BYPASS HEART-LUNG MACHINE CONSOLE

    MDR report key: 1933133 · Received December 13, 2010

    Report

    Report Number
    1718850-2010-00172
    Event Type
    Other
    Date Received
    December 13, 2010
    Date of Event
    January 16, 2010
    Report Date
    November 18, 2010
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) REC'D A REPORT THAT THE PUMP STOPPED DURING THE CASE. THE CARDIOTECHNICIAN HAND CRANKED TO MAINTAIN BLOOD FLOW. THE INVESTIGATION IS ON-GOING. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. THERE WAS NO REPORT OF PT INJURY. THE FACILITY FILED A REPORT WITH THE COUNTRY'S COMPENENT AUTHORITY. THIS MEDWATCH REPORT IS FILED AS A RESULT OF THIS ACTION.

    Description of Event or Problem · 1

    THE CARDIOTECHNICIAN REPORTED THAT THE PUMP STOPPED DURING THE CASE. THE CARDIOTECHNICIAN HAND CRANKED TO MAINTAIN BLOOD FLOW. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOPULMONARY BYPASS HEART-LUNG MACHINE CONSOLE S5 SYSTEM DTQ SORIN GROUP DEUTSCHLAND NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1