BEUDAMED
    FDA Adverse Event Death Summary report: N

    S5 CONSOLE BASE

    MDR report key: 1668786 · Received April 22, 2010

    Report

    Report Number
    1718850-2010-00048
    Event Type
    Death
    Date Received
    April 22, 2010
    Date of Event
    August 8, 2007
    Report Date
    August 9, 2007
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE CUSTOMER REPORTED THAT THERE WAS AIR IN THE ARTERIAL LINE. THE S5 PUMP WAS STOPPED BY THE PERFUSIONIST AND THE LINE CLEARED. THE PERFUSIONIST HAD NOT TURNED ON THE BUBBLE SENSOR WHEN THE AIR WAS NOTED IN THE LINE. AFTER CLEARING AND REPRIMING THE LINE, THE PROCEDURE CONTINUED WITHOUT FURTHER PROBLEMS. THE HLM WAS INVESTIGATED ON SITE BY HOSPITAL STAFF, A SORIN SERVICE TECHNICIAN, AND INDIVIDUALS FROM THE (B) (6) BOARD OF CARDIOTECHNIC, DISTRICT ATTORNEY AND LOCAL POLICE. NO PROBLEMS OR FAULT COULD BE FOUND WITH THE SYSTEM. NO FURTHER ACTION WAS DEEMED NECESSARY.

    Description of Event or Problem · 1

    APPROXIMATELY 3 MINUTES INTO THE PROCEDURE, THE SURGEON NOTED AIR IN THE ARTERIAL LINE. THE S5 PUMP WAS STOPPED AND THE LINE CLEARED. THE PERFUSIONIST HAD NOT TURNED ON THE BUBBLE SENSOR PRIOR TO AIR SEEN IN THE LINE. AFTER CLEARING AND REPRIMING THE LINE, THE PROCEDURE CONTINUED WITHOUT INCIDENT. IT WAS REPORTED THAT THE PATIENT EXPIRED FOUR DAYS AFTER THE CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death