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	05/18/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Haemonetics sent a field service engineer to evaluate the nexsys pcs system.Haemonetics field service engineer found no issues and unit met manufacturers specifications.There was no evidence of a device malfunction found.The disposables were discarded by customer, without physical sample haemonetics is unable to establish cause.
Event or Problem Description
On june 02, 2021, haemonetics was notified of a donor fatality which had occurred within 48 hours of the donor's last plasma donation procedure, utilizing the nexsys pcs system.The plasma collection procedure was completed successfully, no donor reactions or alarms encountered.The nexsys pcs system collected 799ml of pure plasma and 500ml of saline infused.Donor is a previous donor and had donated 10 times this year.The cause of death was reported to be unknown.It is also unknown if an autopsy was performed at this time.

• 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: 12107375
• Report Number: 1219343-2021-00070
• Device Sequence Number: 14503848
• 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: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/02/2021

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: 06/02/2021
• Initial Report FDA Received Date: 07/02/2021
• 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: 30 YR
• Patient Weight: 96