BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEXSYS PCS SYSTEM

    MDR report key: 11611490 · Received April 2, 2021

    Report

    Report Number
    1219343-2021-00107
    Event Type
    Death
    Date Received
    April 2, 2021
    Date of Event
    February 20, 2021
    Report Date
    March 3, 2021
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    UDI-DI
    30812747011659
    PMA / PMN Number
    BK180185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 FOUND NO ISSUES AND UNIT MET MANUFACTURERS SPECIFICATIONS. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION FOUND. THE DISPOSABLES WERE DISCARDED BY CUSTOMER, WITHOUT PHYSICAL SAMPLE HAEMONETICS IS UNABLE TO ESTABLISH CAUSE.

    Description of Event or Problem · 1

    ON MARCH 03, 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. THERE WERE NO ABNORMALITIES MENTIONED EXCEPT AN ELEVATED BLOOD PRESSURE, ALL OTHER TEST RESULTS WERE WITHIN ACCEPTABLE RANGE. THE NEXSYS PCS SYSTEM COLLECTED 750ML OF PURE PLASMA AND 500ML OF SALINE INFUSED. THIS WAS THE DONORS FIRST DONATION AT THE CENTER. THE CAUSE OF DEATH WAS REPORTED TO BE DUE TO CONGESTIVE HEART FAILURE. AN AUTOPSY WAS PERFORMED; THERE WAS NO REPORT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505726 NEXSYS PCS SYSTEM NEXSYS PCS, US GKT HAEMONETICS CORPORATION PCS-300-US 30812747011659

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death