BEUDAMED
    FDA Adverse Event Death Summary report: N

    PCS2

    MDR report key: 1908070 · Received November 5, 2010

    Report

    Report Number
    1219343-2010-00004
    Event Type
    Death
    Date Received
    November 5, 2010
    Date of Event
    October 11, 2010
    Report Date
    November 5, 2010
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    PMA / PMN Number
    BK040025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED AND WAS FOUND TO BE FUNCTIONALLY NORMALLY. THERE IS INFORMATION TO SUGGEST THAT THE DEVICE WAS RELATED TO THIS DEATH OF THIS DONOR.

    Description of Event or Problem · 1

    INITIAL REPORT WAS RECEIVED ON (B)(6) 2010: DONOR, POST PROCEDURE, WAS FOUND IN HER CAR IN CARDIAC ARREST. TRANSPORTED TO HOSPITAL AND ADMITTED. PASSED AWAY LATER IN THE EVENING ON (B)(6) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCS2 PLASMAPHERESIS DEVICE GKT HAEMONETICS CORPORATION PCS2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death OF THE PROCEDURE| SODIUM CITRATE 4% ANTICOAGULANT WAS USED AS PART