MAUDE Adverse Event Report: HAEMONETICS CORPORATION NEXSYS PLASMA COLLECTION SYSTEM; PCS-300-US

Model Number PCS-300-US

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

Patient Problem Cardiovascular Insufficiency (4445)

Event Date 10/25/2023

Event Type  Injury  

Manufacturer Narrative

A haemonetics field service engineer performed an inspection of the collection system used in the procedure.Device passed all diagnostics and functional tests without issue.The device meets the specifications required by the manufacturer; no defects found.A review of the dhr reveals no issues during the manufacturing process that would contribute to this complaint.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.The disposables used with the system were discarded, 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 reaction was related to the device or disposables used during the plasmapheresis procedure.

Event Description

A 60-year-old female donor visited the donation center on october 27, 2023 and informed medical staff she experienced a heart attack a few hours after her donation on october 25, 2023.Camera footage of the donor's visit was reviewed by management and there was nothing noted about the donor or their demeanor.No alarms or adjustments occurred during the donation and donor appeared stable while leaving the center.The donor was treated at the hospital and discharged on (b)(6) 2023.All staff who interacted with the donor were interviewed and they all stated that the donor appeared normal and in good health throughout the donation process.The donor visited the center again on november 2, 2023 and dropped off their discharge paperwork and told us they were doing well.There was no reported issues with the equipment or disposables used during the plasmapheresis procedure.

• Brand Name: NEXSYS PLASMA COLLECTION SYSTEM
• Type of Device: PCS-300-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: 18274454
• MDR Text Key: 329835330
• Report Number: 1219343-2023-00019
• 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: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• 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
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2020
• 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): Life Threatening
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 66 KG