BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCS2 PLASMA COLLECTION SYSTEM

    MDR report key: 12060444 · Received June 24, 2021

    Report

    Report Number
    1219343-2021-00047
    Event Type
    Injury
    Date Received
    June 24, 2021
    Date of Event
    May 20, 2021
    Report Date
    June 17, 2021
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    UDI-DI
    30812747011801
    PMA / PMN Number
    BK060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 DID FIND THE BLOOD PUMP ROTOR AND AC PUMP ROTOR TO BE WORN, WHICH IT WAS THEN REPLACED. ALL OTHER PARAMETERS WERE VERIFIED, MACHINE MET MANUFACTURER'S SPECIFICATIONS. THE DISPOSABLES WERE RETURNED TO HAEMONETICS FOR EVALUATION, A VISUAL EVALUATION WAS CONDUCTED AND A BURR WAS IDENTIFIED ON A SECTION OF THE Y-CONNECTOR TUBING. THE RESULTS OF THE EVALUATION ARE STILL PENDING.

    Description of Event or Problem · 1

    ON JUNE 17, 2021, HAEMONETICS WAS NOTIFIED OF A CONFIRMED HEMOLYSIS EVENT WHICH HAD OCCURRED DURING A DONATION PROCEDURE, UTILIZING THE PCS®2 PLASMA COLLECTION SYSTEM. DURING DONATION PROCEDURE DONOR EXPERIENCED LOWER BACK/FLACK PAIN, NAUSEA AND FACIAL PALLOR. DONATION WAS DISCONTINUED AND ALL OF THE RED BLOOD CELLS WERE RETURNED TO DONOR. THERE WERE NO ERRORS NOTED ON THE EQUIPMENT DURING THE PROCEDURE. DONOR WAS LATER TRANSPORTED FROM THE CENTER TO THE HOSPITAL. THE CENTER DID PERFORM A FOLLOW UP ON DONORS' HEALTH STATUS, THE RESULTS OF THIS FOLLOW UP ARE CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955451 PCS2 PLASMA COLLECTION SYSTEM PCS2,LIST NO. 06002-110-NA GKT HAEMONETICS CORPORATION 06002-110-NA 30812747011801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other