BEUDAMED
    FDA Adverse Event Death Summary report: N

    PCS2 PLASMA COLLECTION SYSTEM

    MDR report key: 10881256 · Received November 21, 2020

    Report

    Report Number
    1219343-2020-00114
    Event Type
    Death
    Date Received
    November 21, 2020
    Date of Event
    October 23, 2020
    Report Date
    October 26, 2020
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    UDI-DI
    30812747011900
    PMA / PMN Number
    BK060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    HAEMONETICS SENT A FIELD SERVICE ENGINEER TO EVALUATE THE PCS®2 PLASMA COLLECTION SYSTEM IN ORDER TO CHECK FOR ANY FAULTS, THE MACHINE WAS FOUND TO MEET SPECIFICATIONS AND DID NOT HAVE ANY DEFECTS WHICH REQUIRED REPAIR. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION FOUND.

    Description of Event or Problem · 1

    ON OCTOBER 26 2020, 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 PLASMA COLLECTION PROCEDURE WAS COMPLETED SUCCESSFULLY, NO COMPLICATIONS REPORTED. THE PCS®2 PLASMA COLLECTION SYSTEM COLLECTED 878ML PLASMA AND RETURNED 500ML OF SALINE PER THE ROUTINE PROCEDURE. THE DONOR HAD COMPLETED 171 PREVIOUS DONATIONS WITHOUT ANY ISSUES OR REACTIONS RECORDED. BASED ON VIDEO THE CENTER OBSERVED NOTHING OUT OF THE ORDINARY DURING THE DONATION OR WHEN DONOR LEFT THE CENTER. HAEMONETICS WAS NOTIFIED THAT AN AUTOPSY WAS PERFORMED BUT AT THIS TIME CAUSE OF DEATH WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346258 PCS2 PLASMA COLLECTION SYSTEM PCS2,LIST NO. 06002-CP-110 GKT HAEMONETICS CORPORATION 06002-CP-110 30812747011900

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Death