BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEXSYS PLASMA COLLECTION SYSTEM

    MDR report key: 20096237 · Received August 29, 2024

    Report

    Report Number
    1219343-2024-00014
    Event Type
    Death
    Date Received
    August 29, 2024
    Date of Event
    July 30, 2024
    Report Date
    August 29, 2024
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    PMA / PMN Number
    BK180185
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE EQUIPMENT USED DURING THE DONATION WAS NOT AVAILABLE FOR EVALUATION. THERE ARE NO NONCONFORMANCES AGAINST THE DEVICE SERIAL NUMBER AND NO CAPAS RELATED TO THIS COMPLAINT. A REVIEW OF THE DHR SHOWS NO ISSUES DURING MANUFACTURING AND ALL TESTING PASSED. THE DISPOSABLES USED WITH THE SYSTEM WERE DISCARDED, HOWEVER THERE WERE NO RECALLS OR ADVERSE TRENDS RELATED TO THE PRODUCT LOTS USED IN THE PROCEDURE. THERE IS NO EVIDENCE TO SUGGEST THAT THE DONOR DEATH WAS RELATED TO THE DEVICE OR DISPOSABLES USED DURING THE PLASMAPHERESIS PROCEDURE.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED TO ALIGN WITH CUSTOMER REPORTING REQUIREMENTS. THE USE OF THE HAEMONETICS MEDICAL DEVICE IN THE DONATION PROCEDURE IS NOT SUSPECTED TO HAVE RESULTED IN THE ADVERSE OUTCOME OF THE DONOR. ON AUGUST 8, 2024, CUSTOMER MADE HAEMONETICS AWARE THAT A 44-YEAR-OLD MALE DONOR PASSED AWAY ON (B)(6) 2024 FROM AN UNKNOWN CAUSE AS REPORTED BY A FRIEND AND CONFIRMED WITH OBITUARY. DEATH OCCURRED OFF-SITE FROM THE DONATION CENTER. CUSTOMER HAS NO INFORMATION FROM THE ATTENDING PHYSICIAN, SURGEON, HOSPITAL REPRESENTATIVE OR HEALTH CARE PROFESSIONAL REGARDING THE EVENT. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. DONOR'S LAST DONATION OCCURRED ON (B)(6) 2024 WITH NO REPORTED ADVERSE EVENT, OR ISSUE WITH THE EQUIPMENT/DISPOSABLES USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1802989 NEXSYS PLASMA COLLECTION SYSTEM PCS-300-US GKT HAEMONETICS CORPORATION PCS-300-US

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male