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	High Blood Pressure/ Hypertension (1908)
Date of Event	04/08/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Haemonetics sent a field service engineer to evaluate the pcs®2 plasma collection system.Haemonetics field service engineer evaluated the unit and there were no problems found.All settings and parameters were verified, unit met manufacturers specifications.The disposables were discarded by customer, without physical sample haemonetics is unable to establish cause.
Event or Problem Description
On june 03, 2021, haemonetics was notified of a donor fatality which occurred within 24 hours of the donor's last plasma donation procedure, utilizing the pcs®2 plasma collection system.Although donation was completed successfully, donor did experience a high pressure return.Post donation donor had experienced a medical emergency in the centers parking lot.The donor was transmitted to the hospital via ambulance where the donor experienced a full cardiac arrest and died the same day.There is no autopsy report available at this time.

• 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: 12120062
• Report Number: 1219343-2021-00084
• Device Sequence Number: 20024648
• Product Code: GKT
• UDI-Device Identifier: 30812747011970
• UDI-Public: (01)30812747011970
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 06/03/2021

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: 06/03/2021
• Initial Report FDA Received Date: 07/06/2021
• 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: 51 YR
• Patient Weight: 114