MAUDE Adverse Event Report: HAEMONETICS CORPORATION PCS®2 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	Sudden Cardiac Death (2510)
Date of Event	05/14/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
There was no adverse reaction or injury experienced during the donation procedure, the donor was reported to have left the center in good health.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 june 27 2019 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 successfully, with no error messages or alarms encountered.The pcs®2 plasma collection system collected the target volume of 880ml of plasma and 500ml of saline administered per the routine procedure.The cause of death was reported to be sudden cardiac arrest; a copy of the coroner's report was available at this time.

• Brand Name: PCS®2 PLASMA COLLECTION SYSTEM
• Common Device Name: PCS2,LIST NO,06002-110-EXP-EW
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• MDR Report Key: 9850881
• Report Number: 1219343-2019-00029
• Device Sequence Number: 743025
• Product Code: GKT
• UDI-Device Identifier: 30812747011970
• UDI-Public: (01)30812747011970
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: BK060033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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: 06/27/2019
• Initial Report FDA Received Date: 03/18/2020
• 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: 25 YR
• Patient Weight: 144