BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEXSYS PCS SYSTEM

    MDR report key: 11777219 · Received May 5, 2021

    Report

    Report Number
    1219343-2021-00113
    Event Type
    Death
    Date Received
    May 5, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 5, 2021
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    UDI-DI
    30812747011659
    PMA / PMN Number
    BK180185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    HAEMONETICS SENT A FIELD SERVICE ENGINEER TO EVALUATE THE NEXSYS PCS SYSTEM. HAEMONETICS FIELD SERVICE ENGINEER INSPECTED THE DEVICE, CALIBRATIONS AND COMPONENTS WERE CHECKED. DEVICE WAS TESTED AND MET MANUFACTURERS SPECIFICATIONS. THE DISPOSABLES WERE DISCARDED BY CUSTOMER, WITHOUT PHYSICAL SAMPLE HAEMONETICS IS UNABLE TO ESTABLISH CAUSE.

    Description of Event or Problem · 1

    ON APRIL 05, 2021, HAEMONETICS WAS NOTIFIED OF A DONOR FATALITY WHICH HAD OCCURRED WITHIN 24 HOURS OF THE DONOR'S LAST PLASMA DONATION PROCEDURE, UTILIZING THE NEXSYS PCS SYSTEM. THE PLASMA COLLECTION PROCEDURE WAS COMPLETED SUCCESSFULLY, NO DONOR REACTIONS OR ALARMS ENCOUNTERED. THE NEXSYS PCS SYSTEM COLLECTED 800ML OF PURE PLASMA AND 500ML OF SALINE INFUSED. DONOR HAD DONATED 4 TIMES PREVIOUSLY. THE CAUSE OF DEATH IS UNKNOWN AND IT IS ALSO UNKNOWN IF AN AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672928 NEXSYS PCS SYSTEM NEXSYS PCS, US GKT HAEMONETICS CORPORATION PCS-300-US 30812747011659

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death