BEUDAMED
    FDA Adverse Event Death Summary report: N

    PCS2,LIST NO. 06002-CP-110

    MDR report key: 19882749 · Received August 1, 2024

    Report

    Report Number
    1219343-2024-00012
    Event Type
    Death
    Date Received
    August 1, 2024
    Date of Event
    July 2, 2024
    Report Date
    November 15, 2024
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    PMA / PMN Number
    BK920039
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT UPDATES: B.4, B.5, G.6, H.2.

    Additional Manufacturer Narrative · 0

    A HAEMONETICS FIELD SERVICE ENGINEER EVALUATED THE EQUIPMENT USED DURING THE DONATION. DEVICE WAS TESTED AND NO PROBLEM WAS FOUND. ALL OTHER PARAMETERS VERIFIED. FUNCTION TESTS COMPLETED. MACHINE MEETS MANUFACTURER'S SPECIFICATIONS AND IS READY TO USE. BASED ON THIS DESCRIPTION THE DEVICE IS EVALUATED WITH NO DEFECT. 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

    CUSTOMER PROVIDED AUTOPSY REPORT ON (B)(6)2024. FINAL AUTOPSY REPORT RECEIVED FROM (B)(6) MEDICAL EXAMINER IN (B)(6) REPORTS CAUSE OF DEATH AS COCAINE TOXICITY AND MANNER OF DEATH AS ACCIDENTAL.

    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 JULY 12, 2024, CUSTOMER MADE HAEMONETICS AWARE THAT A 57-YEAR-OLD MALE DONOR PASSED AWAY ON (B)(6) 2024 FROM AN UNKNOWN CAUSE AT AN UNKNOWN LOCATION AS REPORTED BY HIS GIRLFRIEND. AN AUTOPSY WAS APPARENTLY PERFORMED, BUT IT WILL NOT BE AVAILABLE FOR FOUR MONTHS. CUSTOMER HAS NO INFORMATION FROM THE ATTENDING PHYSICIAN, SURGEON, HOSPITAL REPRESENTATIVE OR HEALTH CARE PROFESSIONAL REGARDING THE EVENT. DONOR'S LAST DONATION OCCURRED ON (B)(6) 2024 WITH NO REPORTED ADVERSE EVENT, OR ISSUE WITH THE EQUIPMENT/DISPOSABLES USED IN THE PROCEDURE. DONOR HAD DONATED 8 TIMES IN THE PAST 12 MONTHS. PRE-DONATION VITAL SIGNS AND BLOOD VALUES ON (B)(6) 2024, DAY OF LAST DONATION: B/P: 116/71. PULSE: 67 BPM. TEMPERATURE: 97.5F. HCT: 50%. TOTAL PROTEIN: 6.0 G/DL. THE FOLLOWING DONOR DEFERRALS WERE REPORTED ON PREVIOUS DONATIONS: (B)(6) 2024 UNACCEPTABLE HEMATOCRIT (56%), (B)(6) 2024 UNACCEPTABLE HEMATOCRIT (59%), (B)(6) 2024 SAME (55%), (B)(6) 2024 SAME (58%), AND 7 MORE UNACCEPTABLE HEMATOCRIT IN 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2249071 PCS2,LIST NO. 06002-CP-110 06002-CP-110 GKT HAEMONETICS CORPORATION 06002-CP-110

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male