BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAEMOLITE 3

    MDR report key: 378912 · Received February 28, 2002

    Report

    Report Number
    1219343-2002-00001
    Event Type
    Death
    Date Received
    February 28, 2002
    Date of Event
    January 28, 2002
    Report Date
    February 28, 2002
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    CAC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AFTER RUNNING AN ELECTIVE AORTIC ANEURYSM REPAIR FOR 9 HOURS (20 BONLS). THE CUSTOMER RECEIVED A PUMP ERROR MESSAGE. THE CUSTOMER CALLED THE HAEMONETICS HOTLINE AND HAEMONETICS ADVISED THEM TO CHECK THE PUMP TUBING AND CLEAN THE PUMP. HAEMONETICS RECEIVED A CALL THE FOLLOWING MORNING THAT THE PT DIED AND THAT IT WAS HOSPITAL POLICY TO HAVE THE MACHINE CHECKED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAEMOLITE 3 AUTO TRANSFUSION CAC HAEMONETICS CORP. 01800-120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death