MAUDE Adverse Event Report: HAEMONETICS CORPORATION NEXSYS PCS SYSTEM; NEXSYS PCS, US, PRODUCT CODE: GKT

Model Number	PCS-300-US
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being sent as part of a service record retrospective review that was self identified by haemonetics.The following parts were sent to customer biomed for repair: pcb,assy,cpu,pcs2,k.1, pcb,assy,driver,pcs2, pcb, assy, safety, pcs2, 8150, pcb assy, centrifuge dist.Brd, scr,pan sems phil sz#8-32x.38, calibration plug, jumper,terminal strip, power entry module assembly, rotor assembly,blood/ac, label,a/c pump.The suspect device/part was not returned to haemonetics, without physical sample provided for evaluation, the root cause cannot be determined.
Event or Problem Description
Haemonetics was notified that a customer reported driver board/ safety board and cpu board as the power supply burnt them all and orange jumper and ac pump rotor and pem and splices and line sensor kit and centrifuge dist board.There was no donor involvement.

• Brand Name: NEXSYS PCS SYSTEM
• Common Device Name: NEXSYS PCS, US, PRODUCT CODE: GKT
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 11812275
• Report Number: 1219343-2021-00081
• Device Sequence Number: 3747756
• Product Code: GKT
• UDI-Device Identifier: 30812747011659
• UDI-Public: (01)30812747011659
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK180185
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PCS-300-US
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1