BEUDAMED
    FDA Adverse Event Death Summary report: N

    PCS2 PLASMA COLLECTION SYSTEM

    MDR report key: 11174925 · Received January 14, 2021

    Report

    Report Number
    1219343-2020-00145
    Event Type
    Death
    Date Received
    January 14, 2021
    Date of Event
    December 8, 2020
    Report Date
    December 15, 2020
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    UDI-DI
    30812747011970
    PMA / PMN Number
    BK060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 PERFORMED CALIBRATION VERIFICATION WITH NO ISSUES, UNIT MET MANUFACTURER 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 DECEMBER 15 2020, HAEMONETICS WAS NOTIFIED OF A DONOR FATALITY WHICH HAD OCCURRED WITHIN 24 HOURS OF THE DONOR'S LAST ATTEMPTED DONATION PROCEDURE, UTILIZING THE PCS®2 PLASMA COLLECTION SYSTEM. NO PLASMA WAS COLLECTED DURING DONATION PROCEDURE AS PROCEDURE WAS STOPPED DUE TO A RBC LESS THAN ERROR CODE. THE DONOR WAS A PREVIOUS DONOR WITH ONE REPORTED REACTION OF AN UNDERDRAW. ON DAY OF DONATION DONOR WAS PROVIDED AN ELECTROLYTE DRINK AND LEFT THE CENTER IN GOOD HEALTH. HAEMONETICS WAS NOTIFIED THAT THE CAUSE OF DEATH WAS A HEART ATTACK, CAUSE OF DEATH WAS NOT CONFIRMED THROUGH AUTOPSY REPORT AS AUTOPSY REPORT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65346 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 56 YR Death| O