MAUDE Adverse Event Report: HAEMONETICS CORPORATION PCS2 PLASMA COLLECTION SYSTEM; PCS2, LIST NO. 06002-220-EXP

Model Number	06002-220-EXP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Blood or Lymphatic problem (4434)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A haemonetics field service engineer evaluated the pcs®2 plasma collection system.A durometer test was carried out; blood pump and ac pump rotors were confirmed functional, cleaned and ready for use.The centrifuge was also checked and all functional tests passed on the equipment.Haemonetics field service engineer found no issues and unit met manufacturers specifications.There was no evidence of a device malfunction found.
Event or Problem Description
On (b)(6) 2021 haemonetics was notified of higher return pressure which occurred at the end of a donation in (b)(4), utilizing the pcs®2 plasma collection system.The donation was stopped due to the blood in the tube being viscous.Shortly after procedure was stopped operator noticed that the collected plasma of approx.230ml was clotted.Donor was sent to the hospital and was released the same day, there were no abnormal findings.

• Brand Name: PCS2 PLASMA COLLECTION SYSTEM
• Common Device Name: PCS2, LIST NO. 06002-220-EXP
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 11609351
• Report Number: 1219343-2021-00106
• Device Sequence Number: 3291879
• Product Code: GKT
• UDI-Device Identifier: 30812747011956
• UDI-Public: (01)30812747011956
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/04/2021

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: 06002-220-EXP
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 04/02/2021
• 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: Required Intervention