MAUDE Adverse Event Report: HAEMONETICS CORPORATION PCS2 PLASMA COLLECTION SYSTEM; PCS2,LIST NO,LN06002-110-NA-EW

Model Number	06002-110-NA-EW
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no donor involved in the incident.The display cable/signal was not returned to haemonetics, without physical sample provided for evaluation the root cause could not be determined.
Event or Problem Description
On (b)(6) 2020 haemonetics was notified of a pcs®2 plasma collection system display cable/signal being burnt.

• Brand Name: PCS2 PLASMA COLLECTION SYSTEM
• Common Device Name: PCS2,LIST NO,LN06002-110-NA-EW
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 10669185
• Report Number: 1219343-2020-00098
• Device Sequence Number: 19458843
• Product Code: GKT
• UDI-Device Identifier: 30812747011819
• UDI-Public: (01)30812747011819
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK150292
• 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): 01/28/2020

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: 06002-110-NA-EW
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1