BEUDAMED
    FDA Adverse Event Death Summary report: N

    PCS®2 PLASMA COLLECTION SYSTEM

    MDR report key: 20313918 · Received September 26, 2024

    Report

    Report Number
    1219343-2024-00016
    Event Type
    Death
    Date Received
    September 26, 2024
    Date of Event
    August 27, 2024
    Report Date
    September 26, 2024
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    UDI-DI
    30812747011819
    PMA / PMN Number
    BK060033
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A HAEMONETICS FIELD SERVICE ENGINEER EVALUATED THE DEVICE USED DURING THE DONATION. DEVICE WAS TESTED AND NO PROBLEM WAS FOUND; PASSED DIAGNOSTIC AND FUNCTIONAL TESTING. MACHINE MEETS MANUFACTURER'S SPECIFICATIONS AND IS READY TO USE. BASED ON THIS DESCRIPTION, THE DEVICE IS EVALUATED WITH NO DEFECT. THERE ARE NO NONCONFORMANCE'S 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 SEPTEMBER 4, 2024, CUSTOMER MADE HAEMONETICS AWARE THAT A 72-YEAR-OLD FEMALE DONOR PASSED AWAY ON (B)(6) 2024 FROM AN UNKNOWN CAUSE AS REPORTED BY ANOTHER DONOR. DONOR'S LAST DONATION OCCURRED ON (B)(6) 2024; SHE WAS A FIRST-TIME DONOR. DURING THE DONATION PROCESS, THE NEEDLE BECAME DISLODGED, RESULTING IN BLEEDING. THE DONOR DID NOT RECEIVE A RESTICK, HAD LESS THAN 200 ML CELL LOSS AND DID NOT EXPERIENCE A DAE. THE CENTER PROVIDED DONOR WITH ELECTROLYTE SOLUTION AND HAD DONOR WAIT 15 MINUTES. DONOR STATED THAT SHE WAS FEELING WELL PRIOR TO EXITING THE CENTER. PER DISTRICT 19 MEDICAL EXAMINERS OFFICE SERVING (B)(6), THE DEATH WAS REPORTED FROM (B)(6) HOSPITAL. CUSTOMER HAS NO INFORMATION FROM THE ATTENDING PHYSICIAN, SURGEON, HOSPITAL REPRESENTATIVE OR HEALTH CARE PROFESSIONAL REGARDING THE EVENT. NO AUTOPSY OR TOXICOLOGY TESTING WAS PERFORMED BY THE MEDICAL EXAMINER SERVING (B)(6). THE MEDICAL EXAMINER'S OFFICE DEEMED THE DONOR'S DEATH "NON-ME" AND DECLINED JURISDICTION OF THE CASE. THERE WERE NO REPORTED ISSUES WITH THE EQUIPMENT OR DISPOSABLES USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684525 PCS®2 PLASMA COLLECTION SYSTEM PCS2,LIST NO,LN06002-110-NA-EW GKT HAEMONETICS CORPORATION 06002-110-NA-EW 30812747011819

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female