BEUDAMED
    FDA Adverse Event Death Summary report: N

    PCS2 PLASMA COLLECTION SYSTEM

    MDR report key: 10518925 · Received September 10, 2020

    Report

    Report Number
    1219343-2020-00081
    Event Type
    Death
    Date Received
    September 10, 2020
    Date of Event
    June 29, 2020
    Report Date
    August 19, 2020
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    UDI-DI
    30812747011970
    PMA / PMN Number
    BK060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO ADVERSE REACTION OR INJURY EXPERIENCED DURING THE DONATION PROCEDURE. 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 PCS2 PLASMA COLLECTION SYSTEM. THE PLASMA COLLECTION PROCEDURE WAS COMPLETED SUCCESSFULLY, COLLECTING 879ML OF PLASMA. BASED ON INFORMATION PROVIDED TO THE CUSTOMER, THE CAUSE OF DEATH WAS REPORTED TO BE OF NATURAL CAUSES, HOWEVER A COPY OF THE MEDICAL EXAMINER'S REPORT WAS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982219 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 57 YR Death