MAUDE Adverse Event Report: HAEMONETICS CORPORATION NEXSYS PLASMA COLLECTION SYSTEM; NEXSYS PCS, 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	10/28/2021
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2021, haemonetics was made aware of a donor fatality which occurred within 48 hours of an apheresis procedure utilizing the nexsys plasma collection system.Donor was a (b)(6)-year-old female who was noted to have expired on (b)(6) 2021 due to an unknown cause.She has donated since (b)(6) 2018 and donated 8-9 times per month in the past several months.Donor's last donation was (b)(6) 2021.No significant information or medical problems were noted on the date of last donation.Review of chart noted a normal physical exam (b)(6) 2021.Most recent labs and test results were also normal.Donor's record noted she had a history of anxiety, mood problems and hypertension for which she was taking zoloft, wellbutrin and metoprolol.Review of vitals were normal on date of last donation.In the past, donor was noted to have 2 out of limit pulses on (b)(6) 2019, 103 bpm and (b)(6) 2019, 123 bpm.She was also noted to have had 2 hypotensive reactions.These included a donor reaction worksheet for hypotensive/vasovagal reaction on (b)(6) 2020 and a hypotensive/vasovagal reaction that required a medical incident report and temporary deferral on (b)(6) 2020.After the medical incident donor "left ok medically" and was found to be suitable for future donations.No other significant information was obtained from reviewing donor's record.The donor did not experience any issues, events or alarms during the donation procedure and there were no issues noted with the disposables used.The plasma donation procedure was completed successfully with 800 ml of plasma collected.Donor has previously donated with no reactions.
Additional Manufacturer Narrative
The cause of death is unknown, however, comments from individuals on (b)(6) state that she fell asleep and never woke up.The center does not have access to the autopsy report.The center has not received any additional information on this case and no further request from the center will be made.A haemonetics field service engineer evaluated the nexsys plasma collection system used by the donor.Diagnostics, functional test and visual inspections were performed and all systems passed.The nexsys device was found to have met manufacturer specifications with no malfunction found.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 fatality was related to the device or disposables used during the plasmapheresis procedure.

• Brand Name: NEXSYS PLASMA COLLECTION SYSTEM
• Common Device Name: NEXSYS PCS, US
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer Contact: brenda bruyere ; 125 summer street; boston, MA 02110
• MDR Report Key: 12887496
• Report Number: 1219343-2021-00147
• Device Sequence Number: 13813297
• Product Code: GKT
• UDI-Device Identifier: 30812747011659
• UDI-Public: (01)30812747011659
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 11/29/2021

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: 11/04/2021
• Initial Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2018
• 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: 34 YR
• Patient Sex: Female
• Patient Weight: 87 KG