MAUDE Adverse Event Report: HAEMONETICS CORPORATION NEXSYS PLASMA COLLECTION SYSTEM; PCS-300-US

Model Number	PCS-300-US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
A field service engineer performed an inspection of the collection system used in the procedure.All parameters were verified.The machine meets the manufacturer's specifications and is ready to use.The device was evaluated with no defect.A review of the dhr reveals no issues during the manufacturing process that would contribute to this complaint.The device was manufactured according to approved procedures and met all specifications for release, with no noted manufacturing deviations, non-conformances or capas that would have contributed to the reported incident.The status of the disposables used with the system is unknown, 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.
Event or Problem Description
The donor was a 47-year-old male qualified donor with 50 lifetime donations at the donor center dating back to (b)(6) 2025.The donor completed an uncomplicated donation on (b)(6) 2026.There were no issues identified with the plasmapheresis device or softgoods used on (b)(6) 2026.Upon review of the donor's record, donor eligibility was determined properly, and the plasmapheresis process was performed per the standard operating procedures.The donor center learned of the donor's death on (b)(6) 2026 when an employee at the donor center who is a friend of the donor's spouse notified center management.According to the information the donor's spouse provided to the center employee, the donor collapsed at home on (b)(6) 2026 (time unknown) and was taken by ems to (b)(6) where he was found to have brain swelling caused by a stroke from blood clots.In addition, he may have also had coronary artery blood clots.He was placed on life support and passed away on (b)(6) 2026 at 4:28 pm.Dr.(b)(6) (director, plasma medical department) contacted the (b)(6) justice of the peace for precinct #1 and they confirmed that the death was not being investigated by their office.This is likely due to the donor passing away while hospitalized and under a physician's care.Therefore, no autopsy will be performed for the purposes of a medical examiner / coroner investigation.

• Brand Name: NEXSYS PLASMA COLLECTION SYSTEM
• Common Device Name: PCS-300-US
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer (Section G): SANMINA PENANG; 202 industrial park; jalan perusahaan maju 9; bukit tengah, perai, penang, 13600 ; MY 13600
• Manufacturer Contact: brenda bruyere ; 125 summer street; boston, MA
• MDR Report Key: 25609437
• Report Number: 3007923088-2026-00001
• Device Sequence Number: 9787264
• Product Code: GKT
• UDI-Device Identifier: 30812747011659
• UDI-Public: (01)30812747011659
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK180185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PCS-300-US
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 47 YR
• Patient Sex: Male