BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUDBURY MEM HSP ONTARIO CAN 1

    MDR report key: 2577631 · Received May 1, 2012

    Report

    Report Number
    1718850-2012-00046
    Event Type
    Other
    Date Received
    May 1, 2012
    Date of Event
    April 5, 2012
    Report Date
    April 6, 2012
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWF
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP HAS REQUESTED THAT THE PRODUCT BE RETURNED FOR EVAL. TO DATE, NO PRODUCT HAS BEEN RETURNED. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. THE HOSPITAL ALLEGED THAT THERE WAS A POTENTIAL FOR AIR TO ENTER THE PT. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS STATEMENT.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE ONE-WAY VALVE WAS PLACED BACKWARDS IN THE VENT LINE. ALTHOUGH, THE LINE WAS CONNECTED TO THE PT, THERE WAS NO REPORT OF ANY AIR ENTERING THE CIRCUIT. THERE WAS NO PT INJURY. THE PT'S CONDITION WAS REASSESSED BY THE PHYSICIAN THE NEXT DAY AND NO NEUROLOGICAL DEFICITS WERE SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUDBURY MEM HSP ONTARIO CAN 1 CUSTOM PERFUSION PACK DWF SORIN GROUP USA, INC. NA 1200500037

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR