BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEXSYS PCS

    MDR report key: 10591243 · Received September 27, 2020

    Report

    Report Number
    1219343-2020-00084
    Event Type
    Death
    Date Received
    September 27, 2020
    Date of Event
    September 2, 2020
    Report Date
    September 14, 2020
    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

    THERE WAS NO ADVERSE REACTION OR INJURY EXPERIENCED DURING THE DONATION PROCEDURE. NO SIGNIFICANT INFORMATION OR PROBLEMS WERE NOTED ON LAST DATE OF DONATION. A HAEMONETICS FIELD SERVICE ENGINEER EVALUATED THE SUSPECTED DEVICE AND FOUND THAT THE UNIT MEETS ALL SPECIFICATIONS, THERE WERE NO FAULTS OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2020 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. THE PLASMA COLLECTION PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO ERROR MESSAGES OR ALARMS ENCOUNTERED. THE NEXSYS PCS COLLECTED VOLUME OF 904ML OF PLASMA AND 500ML OF SALINE ADMINISTERED PER THE ROUTINE PROCEDURE. THE CAUSE OF DEATH WAS REPORTED TO BE UNKNOWN, A COPY OF THE CORONER'S REPORT WAS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055856 NEXSYS PCS NEXSYS PCS, US GKT HAEMONETICS CORPORATION PCS-300-US 30812747011659

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death