BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCS2 PLASMA COLLECTION SYSTEM

    MDR report key: 12093827 · Received June 30, 2021

    Report

    Report Number
    1219343-2021-00059
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    April 7, 2021
    Report Date
    June 1, 2021
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    UDI-DI
    30812747011970
    PMA / PMN Number
    BK060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 FOUND NO ISSUES AND UNIT MET MANUFACTURERS SPECIFICATIONS. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION FOUND. DHR SHOWS THE DEVICE MET SPECIFICATIONS AT FINAL MANUFACTURING TESTS. THE DISPOSABLES WERE DISCARDED BY CUSTOMER, WITHOUT PHYSICAL SAMPLE HAEMONETICS IS UNABLE TO ESTABLISH CAUSE.

    Description of Event or Problem · 1

    ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF TRANSIENT ISCHEMIC ATTACK SYMPTOMS WHICH WAS OBSERVED POST PROCEDURE UTILIZING THE PCS®2 PLASMA COLLECTION SYSTEM. THE COLLECTION WAS COMPLETE WITH NO ERRORS OR EXCEPTIONS. POST PROCEDURE DONOR REPORTED EXPERIENCING RIGHT SIDE FACIAL NUMBNESS AND TINGLING. UPON EVALUATION CENTER STAFF MEMBER OBSERVED THAT DONOR WAS EXPERIENCING RIGHT SIDED FACIAL DROOPING AND SLURRED SPEECH. THE DONOR WAS THEN TRANSPORTED TO THE HOSPITAL VIA AMBULANCE. BASED ON EVALUATION FROM PHYSICIAN DONORS SYMPTOMS WERE NOT RELATED TO STROKE, DONOR WAS LATER DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990682 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 Other