MAUDE Adverse Event Report: HAEMONETICS CORPORATION PCS2,LIST NO. 06002-CP-110

Model Number 06002-CP-110

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2024

Event Type  Death  

Manufacturer Narrative

Haemonetics field service engineer was dispatched to inspect the pcs®2 plasma collection system.The field service engineer found no issues with the device.Function tests were completed.The device meets manufacturer's specifications and is ready to use.There are no nonconformances against this serial number.There are no capas related to this complaint.A review of the device history records shows no issues during manufacturing and all testing passed.There were no issues, events or alarms noted with the equipment used during the procedure and there were no issues noted with the disposables.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 fatality was related to the device or disposables used during the plasmapheresis procedure.

Event Description

This report is being submitted to align with customer reporting requirements.The use of the haemonetics medical device in the donation procedure is not suspected to have resulted in the adverse outcome of the donor.Customer reported on april 9, 2024, a 48-year-old donor passed away from natural causes resulting from atherosclerotic and cardiovascular disease at his home on (b)(6) 2024.The death was reported by the deceased fiancée.There was no autopsy or toxicology performed by the medical examiner.The donor completed a full donation with no collection exceptions or issues on (b)(6) 2024 and was disconnected at 14:06.There were no reported issues with the equipment or disposables used during the procedure.

• Brand Name: PCS2,LIST NO. 06002-CP-110
• Type of Device: 06002-CP-110
• 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 02110
• MDR Report Key: 19134649
• MDR Text Key: 340502721
• Report Number: 1219343-2024-00007
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK920039
• 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: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 06002-CP-110
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2005
• 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 Age: 48 YR
• Patient Sex: Male
• Patient Weight: 117 KG