BEUDAMED
    FDA Adverse Event Death Summary report: N

    PCS2 PLASMA COLLECTION SYSTEM

    MDR report key: 12026333 · Received June 18, 2021

    Report

    Report Number
    1219343-2021-00042
    Event Type
    Death
    Date Received
    June 18, 2021
    Date of Event
    May 9, 2021
    Report Date
    May 19, 2021
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    UDI-DI
    30812747011970
    PMA / PMN Number
    BK060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    HAEMONETICS SENT A FIELD SERVICE ENGINEER TO EVALUATE THE PCS¿2 PLASMA COLLECTION SYSTEM. HAEMONETICS FIELD SERVICE ENGINEER EVALUATED THE UNIT AND THE UNIT WAS OPERATING WITHIN SPECIFICATIONS. THE DISPOSABLES WERE DISCARDED BY CUSTOMER, WITHOUT PHYSICAL SAMPLE HAEMONETICS IS UNABLE TO ESTABLISH CAUSE.

    Description of Event or Problem · 1

    ON MAY 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 PCS¿2 PLASMA COLLECTION SYSTEM. THE WERE NO ERRORS OBSERVED DURING DONATION. 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
    923590 PCS2 PLASMA COLLECTION SYSTEM PCS2,LIST NO,06002-110-EXP-EW GKT HAEMONETICS CORPORATION 06002-110-EXP-EW 30812747011970

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death