MAUDE Adverse Event Report: HAEMONETICS CORPORATION NEXSYS PCS SYSTEM; NEXSYS PCS, US

Model Number	PCS-300-US
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The center was notified of death by donors significant other.The cause of death is unknown as the center does not have access to any autopsy report.The center has not received any additional information and no further request from the center will be made.Haemonetics sent a field service engineer to evaluate the nexsys plasma collection system.Haemonetics field service engineer inspected the unit, performed the diagnostics and calibrations tests.Unit passed all testing and calibrations, unit meet manufacturer's specifications.The disposables were discarded by customer, without physical sample to evaluate haemonetics is unable to establish cause.
Event or Problem Description
On august 19, 2021, haemonetics was notified of a donor fatality which had occurred within 24 hours of the donor's last plasma donation procedure, utilizing the nexsys plasma collection system.No significant information or adverse events were noted on the last date of donation.Review of vitals were normal on date of last donation; however, donor was noted to have several deferrals for out of limit diastolic blood pressures and one deferral for an out of limit pulse.The plasma donation procedure was completed successfully with 800 ml of pure plasma collected.

• Brand Name: NEXSYS PCS SYSTEM
• Common Device Name: NEXSYS PCS, US
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 12483101
• Report Number: 1219343-2021-00124
• Device Sequence Number: 14675513
• Product Code: GKT
• UDI-Device Identifier: 30812747011659
• UDI-Public: (01)30812747011659
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/19/2021

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: 08/19/2021
• Initial Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 37 YR
• Patient Weight: 111