MAUDE Adverse Event Report: HAEMONETICS CORPORATION PCS2 SYSTEM; PCS2,LIST NO,LN06002-110-NA

Model Number	06002-110-NA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiovascular Dysfunction/Insufficiency (4445)
Date of Event	10/19/2024
Type of Reportable Event	Death
Event or Problem 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 made haemonetics aware that a 42-year-old female donor passed away in her residence on (b)(6) 2024 from a hypertensive cardiovascular disease per the medical examiner.An autopsy was not performed.The center has no information from attending physician, surgeon, hospital representative or health care professional.The donor did not experience a reaction or adverse event and there were no errors on the machine or issues reported with the disposables during the donor's last donation on (b)(6) 2024.
Additional Manufacturer Narrative
A haemonetics field service engineer performed an inspection of the collection system used in the procedure.All parameters were verified.The machine meets the manufacturer's specifications and is ready to use.The device was evaluated with no defect.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 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 is no evidence to suggest that the donor death was related to the device or disposables used during the plasmapheresis procedure.

• Brand Name: PCS2 SYSTEM
• Common Device Name: PCS2,LIST NO,LN06002-110-NA
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston 02110
• Manufacturer Contact: brenda bruyere ; 125 summer street; boston
• MDR Report Key: 20763564
• Report Number: 1219343-2024-00022
• Device Sequence Number: 18283168
• Product Code: GKT
• UDI-Device Identifier: 30812747011819
• UDI-Public: (01)30812747011819
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: BK920039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 06002-110-NA
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 106 KG