BEUDAMED
    FDA Adverse Event Death Summary report: N

    PCS2 PLASMA COLLECTION SYSTEM

    MDR report key: 10769763 · Received November 2, 2020

    Report

    Report Number
    1219343-2020-00103
    Event Type
    Death
    Date Received
    November 2, 2020
    Date of Event
    September 26, 2020
    Report Date
    October 17, 2020
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    UDI-DI
    30812747011970
    PMA / PMN Number
    BK060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    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 OCTOBER 17 2020 HAEMONETICS WAS NOTIFIED OF A DONOR FATALITY WHICH HAD OCCURRED WITHIN 48 HOURS OF THE DONOR'S LAST PLASMA DONATION PROCEDURE, UTILIZING THE PCS®2 PLASMA COLLECTION SYSTEM. THE PLASMA COLLECTION PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO ERROR MESSAGES OR ALARMS ENCOUNTERED. THERE WAS NO ADVERSE REACTION OR INJURY EXPERIENCED DURING THE PROCEDURE. THE PCS®2 PLASMA COLLECTION SYSTEM COLLECTED 825ML OF PLASMA. THE CAUSE OF DEATH WAS REPORTED TO BE A SUDDEN CARDIAC DEATH; HOWEVER, A COPY OF THE CORONER'S REPORT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233764 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 51 YR Death