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	Insufficient Information (4580)
Date of Event	06/21/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
This report was received when customer called in for service.At this time patient info, patient medical history, patient signs/symptoms and equipment availability are currently unavailable.Haemonetics is working with customer to obtain needed information, once obtained, report will be updated.
Event or Problem Description
On (b)(6) 2021, haemonetics was notified of a donor fatality utilizing the pcs¿2 plasma collection system.
Additional Manufacturer Narrative
Report is being retracted due to further communication to the site as they confirmed that no adverse event or death occurred.The original report was made due to a service site visit description which was an error.Report retracted.

• 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: 12202090
• Report Number: 1219343-2021-00098
• Device Sequence Number: 4370616
• Product Code: GKT
• UDI-Device Identifier: 30812747011970
• UDI-Public: (01)30812747011970
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

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
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 07/26/2021
• 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