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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
A haemonetics field service engineer evaluated the suspected device and found that the unit meets all specifications, there were no faults observed.
Event or Problem Description
On october 17 2020 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, with no error messages or alarms encountered.There was no adverse reaction or injury experienced during the procedure.The pcs®2 plasma collection system collected 825ml of plasma.The cause of death was reported to be a sudden cardiac death; however, a copy of the coroner's 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: 10769763
• Report Number: 1219343-2020-00103
• Device Sequence Number: 3799333
• 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): 10/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 10/17/2020
• Initial Report FDA Received Date: 11/02/2020
• 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: 51 YR
• Patient Weight: 73