BEUDAMED
    FDA Adverse Event Other Summary report: N

    MT SINAI HSP NEW YORK NY1

    MDR report key: 2543113 · Received March 28, 2012

    Report

    Report Number
    1718850-2012-00022
    Event Type
    Other
    Date Received
    March 28, 2012
    Date of Event
    February 28, 2012
    Report Date
    February 28, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP RECEIVED A REPORT THAT THE ATRIAL LINE CAME OFF OF THE ARTERIAL OUTLET PORT OF THE OXYGENATOR DURING BYPASS RESULTING IN ABOUT 300-400 CC OF BLOOD LOSS. BYPASS WAS TERMINATED, THE TUBING WAS RECONNECTED TO THE OXYGENATOR AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. NO BLOOD WAS GIVEN AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT THE PT IS DOING WELL. A SORIN REPRESENTATIVE INSPECTED THE CIRCUIT THE NEXT DAY AT THE FACILITY AND FOUND NO PROBLEMS. BOTH THE 3/8" ARTERIAL TUBING LINE AND THE ARTERIAL OUTLET PORT OF THE OXYGENATOR APPEARED UNDAMAGED. THE SORIN REPRESENTATIVE STATED THAT WHEN THE TUBING WAS CONNECTED TO THE OUTLET PORT, IT APPEARED SECURE AND WAS VERY DIFFICULT TO DISCONNECT. THE CAUSE OF THE DISCONNECTION COULD NOT BE DETERMINED. IN ADDITION, A FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO EVALUATE THE HEART/LUNG MACHINE. NO PROBLEMS WERE FOUND. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE ARTERIAL LINE CAME OFF OF THE ARTERIAL OUTLET PORT OF THE OXYGENATOR DURING BYPASS RESULTING IN ABOUT 300-400 CC OF BLOOD LOSS. BYPASS WAS TERMINATED, THE TUBING WAS RECONNECTED TO THE OXYGENATOR AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. NO BLOOD WAS GIVEN AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MT SINAI HSP NEW YORK NY1 CUSTOMER PERFUSION PACK DWF SORIN GROUP USA, INC. NA 1202500036

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR