BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEXSYS PCS SYSTEM

    MDR report key: 11758302 · Received April 30, 2021

    Report

    Report Number
    1219343-2021-00110
    Event Type
    Death
    Date Received
    April 30, 2021
    Date of Event
    March 28, 2021
    Report Date
    April 1, 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 PROBLEM OR ISSUES FOUND DURING DIAGNOSTICS. MACHINE MEETS MANUFACTURERS SPECIFICATIONS. THE DISPOSABLES WERE DISCARDED BY CUSTOMER, WITHOUT PHYSICAL SAMPLE HAEMONETICS IS UNABLE TO ESTABLISH CAUSE.

    Description of Event or Problem · 1

    ON (B)(6) 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. DURING THE PLASMA COLLECTION PROCEDURE DONOR WAS REPORTED TO HAVE HAD A HYPOTENSIVE/VASOVAGAL REACTION. THE NEXSYS PCS SYSTEM COLLECTED 793ML OF PURE PLASMA AND 500ML OF SALINE INFUSED. DONOR HAD DONATED 7 TIMES PREVIOUSLY, DONORS' VITALS WERE NORMAL ON DATE OF LAST DONATION AND THROUGHOUT THEIR TIME DONATING AT THE CENTER. 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
    648383 NEXSYS PCS SYSTEM NEXSYS PCS, US GKT HAEMONETICS CORPORATION PCS-300-US 30812747011659

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death