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

Model Number	06002-110-EXP-EW
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The center was notified of death by donors significant other.The cause of death is unknown as the center does not have access to any autopsy report.The center received information that the final report is pending toxicology and that there is preliminary evidence to suggest an accidental drug overdose.The center has not received any additional information and no further request from the center will be made.Haemonetics sent a field service engineer to evaluate the pcs¿2 plasma collection system.Haemonetics field service engineer inspected the unit and found all calibrations within specifications and components functioning properly.Unit functional tests were performed and unit met manufacturers specifications.The disposables were discarded by customer, without physical sample to evaluate haemonetics is unable to establish cause.
Event or Problem Description
On (b)(6) 2021, haemonetics was notified of a donor fatality which had occurred within 24 hours of the donor's last plasma donation procedure, utilizing the pcs¿2 plasma collection system.The donor did not experience any issues, events or alarms during donation procedure.There were no issues noted with the disposables during the donation procedure.The plasma donation procedure was completed successfully with 690 ml of plasma collected.Donor has previously donated with no reactions.

• Brand Name: PCS2 PLASMA COLLECTION SYSTEM
• Common Device Name: PCS2,LIST NO,06002-110-EXP-EW
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 12421334
• Report Number: 1219343-2021-00121
• Device Sequence Number: 3662049
• Product Code: GKT
• UDI-Device Identifier: 30812747011970
• UDI-Public: (01)30812747011970
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 08/06/2021
• Initial Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 64 YR
• Patient Weight: 63