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	07/09/2026
Type of Reportable Event	Death
Event or Problem Description
The donor was a 35-year-old male qualified donor with 192 lifetime donations at the donor center dating back to (b)(6)2023.The donor presented for a routine donation on (b)(6)2026 and met all donor eligibility criteria.The donation began at 3:28 pm following a successful venipuncture in the left arm.The donor completed the full donation at 4:09 pm with a total collection volume of 956 ml and a plasma collection volume of 849 ml.The donor received 500 ml of procedural saline at the end of the procedure and 164 ml of anticoagulant was used.There were no collection exceptions or donor adverse events noted during the procedure.The donor center learned of the donor's death on (b)(6)2026 when center staff noted a social media post suggesting that the donor had died.A published online obituary confirmed that the donor died on (b)(6)2026.The obituary indicated that the donor died suddenly but no other information about the cause of death or circumstances surrounding the death was included in the obituary.Dr.(b)(6)(director, plasma medical department) contacted the (b)(6) and a representative confirmed that their office did not investigate the case.Under the texas code of criminal procedure, counties with smaller populations rely primarily on justices of the peace to act as coroners.Dr.(b)(6) also contacted the (b)(6) and a representative confirmed that the donor died at the (b)(6) and that they had not yet received a copy of the death certificate.No other information was available regarding the cause of 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.

• 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-SCI Systems; 202 lorong perushaan maju 9; bukit tengah industrial park; penang pulau pinang, 13600 ; MY 13600
• Manufacturer Contact: brenda bruyere ; 202 lorong perushaan maju 9; bukit tengah industrial park; boston, perai pulau pinang 13600 ; MY 13600
• MDR Report Key: 50308405
• Report Number: 3007923088-2026-00002
• Device Sequence Number: 13434022
• Product Code: GKT
• UDI-Device Identifier: 30812747011659
• UDI-Public: (01)30812747011659
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/18/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2020
• 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: 35 YR
• Patient Sex: Male