BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAEMONETICS

    MDR report key: 288763 · Received August 3, 2000

    Report

    Report Number
    1219343-2000-00001
    Event Type
    Death
    Date Received
    August 3, 2000
    Date of Event
    June 30, 2000
    Report Date
    July 5, 2000
    Manufacturer
    HAEMONETICS UK
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS TRANSFUSED WITH PLATELETS ON JUNE 29, 2000. THE PLATELETS HAD BEEN COLLECTED FROM THE DONOR WITH A HAEMONETICS MODEL 994UKF HARNESS SET. DURING THE TRANSFUSION THE PT HAD A REACTION. THE PT DIED WITHIN 24 HRS. NOTE: THIS MODEL NUMBER IS NOT USED IN THE USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAEMONETICS HARNESS SET CAC HAEMONETICS UK 994 UKF QQ0009

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death