BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEXSYS PCS SYSTEM

    MDR report key: 12483101 · Received September 16, 2021

    Report

    Report Number
    1219343-2021-00124
    Event Type
    Death
    Date Received
    September 16, 2021
    Date of Event
    August 1, 2021
    Report Date
    August 19, 2021
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    UDI-DI
    30812747011659
    PMA / PMN Number
    BK180185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE CENTER WAS NOTIFIED OF DEATH BY DONORS SIGNIFICANT OTHER. THE CAUSE OF DEATH IS UNKNOWN AS THE CENTER DOES NOT HAVE ACCESS TO ANY AUTOPSY REPORT. THE CENTER HAS NOT RECEIVED ANY ADDITIONAL INFORMATION AND NO FURTHER REQUEST FROM THE CENTER WILL BE MADE. HAEMONETICS SENT A FIELD SERVICE ENGINEER TO EVALUATE THE NEXSYS PLASMA COLLECTION SYSTEM. HAEMONETICS FIELD SERVICE ENGINEER INSPECTED THE UNIT, PERFORMED THE DIAGNOSTICS AND CALIBRATIONS TESTS. UNIT PASSED ALL TESTING AND CALIBRATIONS, UNIT MEET MANUFACTURER'S SPECIFICATIONS. THE DISPOSABLES WERE DISCARDED BY CUSTOMER, WITHOUT PHYSICAL SAMPLE TO EVALUATE HAEMONETICS IS UNABLE TO ESTABLISH CAUSE.

    Description of Event or Problem · 1

    ON AUGUST 19, 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 PLASMA COLLECTION SYSTEM. NO SIGNIFICANT INFORMATION OR ADVERSE EVENTS WERE NOTED ON THE LAST DATE OF DONATION. REVIEW OF VITALS WERE NORMAL ON DATE OF LAST DONATION; HOWEVER, DONOR WAS NOTED TO HAVE SEVERAL DEFERRALS FOR OUT OF LIMIT DIASTOLIC BLOOD PRESSURES AND ONE DEFERRAL FOR AN OUT OF LIMIT PULSE. THE PLASMA DONATION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 800 ML OF PURE PLASMA COLLECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380594 NEXSYS PCS SYSTEM NEXSYS PCS, US GKT HAEMONETICS CORPORATION PCS-300-US 30812747011659

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death