BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXSYS PCS SYSTEM

    MDR report key: 12530678 · Received September 24, 2021

    Report

    Report Number
    1219343-2021-00125
    Event Type
    Injury
    Date Received
    September 24, 2021
    Date of Event
    August 25, 2021
    Report Date
    August 25, 2021
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    PMA / PMN Number
    BK180185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO DONOR INFORMATION PROVIDED. HAEMONETICS WAS UNABLE TO DETERMINE THE SOURCE OF THIS REPORTED INCIDENT FROM THE MEDWATCH REPORT PROVIDED, WITHOUT THE SOURCE DETAILS HAEMONETICS IS UNABLE TO OBTAIN ANY OTHER INFORMATION. BASED ON THE INFORMATION PROVIDED HAEMONETICS WAS ALSO UNABLE TO IDENTIFY WHICH PLASMA CENTER DONOR WAS REFERRING TO.

    Description of Event or Problem · 1

    ON (B)(6) 2021, HAEMONETICS WAS NOTIFIED VIA MEDWATCH REPORT MW5102863 OF A DONOR EXPERIENCING PAIN IN BOTH SHINS, CHEST PAINS, HEADACHES AND DIARRHEA DURING A DONATION PROCEDURE, UTILIZING THE NEXSYS PCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427251 NEXSYS PCS SYSTEM NEXSYS PCS, US GKT HAEMONETICS CORPORATION PCS-300-US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other