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	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Haemonetics sent a field service engineer to evaluate the pcs®2 plasma collection system.Haemonetics field service engineer found no issues and unit met manufacturers specifications.There was no evidence of a device malfunction found.Dhr shows the device met specifications at final manufacturing tests.The disposables were discarded by customer, without physical sample haemonetics is unable to establish cause.
Event or Problem Description
On january 8, 2021, haemonetics was notified of a donor fatality which had occurred within 48 hours of the donor's last plasma donation procedure, utilizing the pcs®2 plasma collection system.The plasma collection procedure was completed successfully, no donor reactions or alarms encountered.The pcs®2 plasma collection system collected 825ml plasma.The donor had completed several previous donations, with 7 deferrals due to high blood pressure.The center was notified by a relative of the passing, the cause of death was unknown and an autopsy report was not available.

• 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: 11289020
• Report Number: 1219343-2021-00004
• Device Sequence Number: 17030058
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/08/2021

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: 01/08/2021
• Initial Report FDA Received Date: 02/05/2021
• 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: 41 YR
• Patient Weight: 76