BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCS+ MOBILE COLLECTION SYSTEM

    MDR report key: 10286413 · Received July 16, 2020

    Report

    Report Number
    1219343-2020-00067
    Event Type
    Injury
    Date Received
    July 16, 2020
    Date of Event
    April 21, 2020
    Report Date
    June 16, 2020
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    UDI-DI
    30812747012945
    PMA / PMN Number
    BK010035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    LIMITED DONOR INFORMATION WAS PROVIDED. A FIELD SERVICE ENGINEER WAS SCHEDULED TO EVALUATE THE MCS®+ MOBILE COLLECTION SYSTEM, THE RESULTS OF THIS EVALUATION IS CURRENTLY UNKNOWN. THE CONCENTRATED PLATELET AND PLASMA SET HAS YET TO BE RETURNED AND EVALUATED BY HAEMONETICS. WITHOUT PHYSICAL SAMPLE PROVIDED FOR EVALUATION THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2020 HAEMONETICS WAS NOTIFIED OF A SEVERE CITRATE REACTION WHICH OCCURRED FOLLOWING A PLATELET DONATION IN (B)(6), UTILIZING THE MCS®+ MOBILE COLLECTION SYSTEM AND CONCENTRATED PLATELET AND PLASMA SET. AFTER THE 11TH CYCLE, ALL PLASMA AND PLATELET RICH PLASMA WAS RETURNED TO THE DONOR WITH NO ERROR MESSAGES OR ALARMS ENCOUNTERED. THE DONORS' HEALTH IMPROVED AFTER RECEIVING CALCIUM CHLORIDE TABLET AND INTRAVENOUS SODIUM CHLORIDE. THE DONOR WAS REPORTED TO HAVE LEFT THE CENTER IN GOOD HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745288 MCS+ MOBILE COLLECTION SYSTEM CONC PLT & PLS SET W/FILTER GKT HAEMONETICS CORPORATION 999F-E 8819107 30812747012945

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other