MAUDE Adverse Event Report: HAEMONETICS CORPORATION PCS®2 PLASMA COLLECTION SYSTEM; PCS2,LIST NO,06002-110-EXP-EW

Model Number	06002-110-EXP-EW
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation is on-going.
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.On september 6, 2024, customer made haemonetics aware that a 40-year-old male donor passed away on (b)(6) 2024.The donor was found near his house unconscious and the cause of death is a heart attack as reported by a family member.Customer has no information from the attending physician, surgeon, hospital representative or health care professional as death occurred off-site from the donation center.An autopsy from the miami-date medical examiner has not been made available to the customer.Donor's last donation occurred on (b)(6) 2024 and there were no reported issues with the equipment or disposables used in the procedure at the time of the donation.The donor did not experience a reaction or adverse event during the (b)(6) 2024 procedure.
Additional Manufacturer Narrative
Device inspection for donor death was completed.All parameters verified and adjusted as required.Function tests completed.Machine meets manufacturer's specifications and is ready to use.Based on the evaluation, the device was evaluated 'no defect' and no evidence was found to show the device contributed to the reported complaint.There are no nces against this serial/lot number.There are no capas related to this complaint.A review of the dhr shows no issues during manufacturing and all testing passed.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 death was related to the device or disposables used during the plasmapheresis procedure.

• Brand Name: PCS®2 PLASMA COLLECTION SYSTEM
• Common Device Name: PCS2,LIST NO,06002-110-EXP-EW
• 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: 20359180
• Report Number: 1219343-2024-00017
• Device Sequence Number: 17944256
• Product Code: GKT
• UDI-Device Identifier: 30812747011970
• UDI-Public: (01)30812747011970
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: BK060033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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-EXP-EW
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2013
• 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: 40 YR
• Patient Sex: Male
• Patient Weight: 195 KG