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

Model Number PCS-300-US

Device Problem Insufficient Information (3190)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 03/28/2021

Event Type  Death  

Manufacturer Narrative

Haemonetics sent a field service engineer to evaluate the nexsys pcs system.Haemonetics field service engineer found no problem or issues found during diagnostics.Machine meets manufacturers specifications.The disposables were discarded by customer, without physical sample haemonetics is unable to establish cause.

Event Description

On (b)(6) 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 pcs system.During the plasma collection procedure donor was reported to have had a hypotensive/vasovagal reaction.The nexsys pcs system collected 793ml of pure plasma and 500ml of saline infused.Donor had donated 7 times previously, donors' vitals were normal on date of last donation and throughout their time donating at the center.The cause of death is unknown and it is also unknown if an autopsy was performed.

• Brand Name: NEXSYS PCS SYSTEM
• Type of Device: 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: janice kiser ; 125 summer street; boston, MA 02110
• MDR Report Key: 11758302
• MDR Text Key: 248370174
• Report Number: 1219343-2021-00110
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 30812747011659
• UDI-Public: (01)30812747011659
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK180185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/01/2021

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
• Device Operator: Health Professional
• Device Model Number: PCS-300-US
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 51 YR
• Patient Weight: 110