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

Model Number PCS-300-US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 10/21/2022

Event Type  Injury  

Manufacturer Narrative

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.A haemonetics field service engineer performed a full function check on the machine and found it met manufacturer specifications and was ready for use.Evaluation conclusion is the device operates as intended and did not contribute to reported event.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 were no equipment errors or issues with the disposables noted during the donation.There is no evidence to suggest that the event was related to the device or disposables used during the plasmapheresis procedure.

Event Description

On (b)(6) 2022, haemonetics was notified of a 52-year-old male who was hospitalized on (b)(6) 2022 two hours after a donation which used a nexsys pcs-300 system.On (b)(6) 2022, the donor presented to donate.It was noted by the center's medical operations supervisor that in conversation, the donor stated that he had not been in a while due to having a stroke in the afternoon/evening of (b)(6) 2022 when he was transported to the nearest hospital for further evaluation and treatment; he was diagnosed with a stroke.Donor donated on (b)(6) 2022 from 9:50am-10:49am.The event occurred several hours after the donor left the center.No issues were noted during the donation that could be determined via surveillance/nexlynk worksheet.Due to donor reporting the event over 45 days post donation, no disposables were able to be physically retrieved.There were no significant donor issues or issues noted with the nexsys system or disposables used during the apheresis procedure.Donor provided documentation from hospital discharge on (b)(6) 2022 that revealed the following diagnosis: cerebrovascular accident, hypokalemia, luekocytosis, hypovolemic shock, acute right-sided weakness and history of right below the knee amputation.

• 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: brenda bruyere ; 125 summer street; boston, MA 02110
• MDR Report Key: 16087233
• MDR Text Key: 306536740
• Report Number: 1219343-2022-00062
• Device Sequence Number: 1
• Product Code: GKT
• 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: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/08/2022

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: 12/08/2022
• Initial Date FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2019
• 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): Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 102 KG