MAUDE Adverse Event Report: HAEMONETICS CORPORATION PCS®2 PLASMA COLLECTION SYSTEM; PCS2,LIST NO,LN06002-110-NA-EW

Model Number	06002-110-NA-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	08/27/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
A haemonetics field service engineer evaluated the device used during the donation.Device was tested and no problem was found; passed diagnostic and functional testing.Machine meets manufacturer's specifications and is ready to use.Based on this description, the device is evaluated with no defect.There are no nonconformance's against the device serial number and 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.
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 4, 2024, customer made haemonetics aware that a 72-year-old female donor passed away on (b)(6) 2024 from an unknown cause as reported by another donor.Donor's last donation occurred on (b)(6) 2024; she was a first-time donor.During the donation process, the needle became dislodged, resulting in bleeding.The donor did not receive a restick, had less than 200 ml cell loss and did not experience a dae.The center provided donor with electrolyte solution and had donor wait 15 minutes.Donor stated that she was feeling well prior to exiting the center.Per district 19 medical examiners office serving (b)(6), the death was reported from (b)(6) hospital.Customer has no information from the attending physician, surgeon, hospital representative or health care professional regarding the event.No autopsy or toxicology testing was performed by the medical examiner serving (b)(6).The medical examiner's office deemed the donor's death "non-me" and declined jurisdiction of the case.There were no reported issues with the equipment or disposables used in the procedure.

• Brand Name: PCS®2 PLASMA COLLECTION SYSTEM
• Common Device Name: PCS2,LIST NO,LN06002-110-NA-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: 20313918
• Report Number: 1219343-2024-00016
• Device Sequence Number: 8099741
• Product Code: GKT
• UDI-Device Identifier: 30812747011819
• UDI-Public: (01)30812747011819
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date (Section B): 09/26/2024

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-EW
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2012
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 71 KG