BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCS®+ 8150 MULTICOMPONENT COLLECTION SYSTEM

    MDR report key: 9986185 · Received April 22, 2020

    Report

    Report Number
    1219343-2020-00034
    Event Type
    Injury
    Date Received
    April 22, 2020
    Date of Event
    March 27, 2020
    Report Date
    March 27, 2020
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    PMA / PMN Number
    BK060023
    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, NO PROBLEM WAS FOUND WITH DEVICE AFTER EXTENSIVE TESTING OF AIR DETECTORS. HAEMONETICS FIELD SERVICE ENGINEER ALSO VERIFIED ALL SETTINGS AND PARAMETERS AND PERFORMED FUNCTIONAL TEST. UNIT MEETS MANUFACTURER'S SPECIFICATIONS AND IS READY FOR CUSTOMER USE.

    Description of Event or Problem · 1

    ON (B)(6) 2020, HAEMONETICS WAS NOTIFIED OF A DEVICE MALFUNCTION, AIR WAS FOUND IN THE RETURN LINE DURING FIRST RETURN OF THE PROCEDURE. THE DONOR WAS TREATED FOR POSSIBLE AIR EMBOLISM BUT THERE WERE NO SYMPTOMS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450858 MCS®+ 8150 MULTICOMPONENT COLLECTION SYSTEM MCS+ (RBC),LIST NO 08150-110-E GKT HAEMONETICS CORPORATION 08150-110-E

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Life Threatening