MAUDE Adverse Event Report: HAEMONETICS CORPORATION PCS2 PLASMA COLLECTION SYSTEM; PCS2, LN, 06002-110-EXS-EW

Model Number	06002-110-EXS-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	10/16/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Haemonetics sent a field service engineer to evaluate the pcs®2 plasma collection system in order to check for any faults, the machine was found to meet specifications and did not have any defects which required repair.There was no evidence of a device malfunction found.
Event or Problem Description
On october 26 2020, 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 plasma collection procedure was completed, the pcs®2 plasma collection system collected 879ml plasma.The donor had completed previous donations without any issues or reactions recorded.Customer was notified by donors family that cause of death was a deep vein thrombosis but an autopsy was not performed at this time and there were no reports available to confirm.

• Brand Name: PCS2 PLASMA COLLECTION SYSTEM
• Common Device Name: PCS2, LN, 06002-110-EXS-EW
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 10883585
• Report Number: 1219343-2020-00115
• Device Sequence Number: 16823285
• Product Code: GKT
• UDI-Device Identifier: 30812747011987
• UDI-Public: (01)30812747011987
• 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): 10/26/2020

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-EXS-EW
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/23/2020
• 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: 28 YR
• Patient Weight: 110