MAUDE Adverse Event Report: HAEMONETICS, INC. CELL SAVER® ELITE® PLUS AUTOTRANSFUSION SYSTEM; CS ELITE PROCESSING KIT, 125ML

Model Number	CSE-P-125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypovolemia (2243)
Date of Event	02/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A haemonetics field service engineer evaluated the data log files from the cell saver elite system used in the procedure.Data showed that the device functioned correctly, tripping to wash @ the correct point.There is no evidence to suggest that the event was related to the device used during the procedure.There was no report of patient adverse reaction in this event.
Event or Problem Description
On (b)(6) 2022, haemonetics was notified of an early wash trigger with an estimated blood loss approximately 1500 ml (pre-op hb/ 97g/dl); cell salvage blood re-infused approximately 114 ml during a procedure using a cell saver® elite® plus autotransfusion system and cell saver® elite set-125m in the (b)(6).There was no report of patient injury.

• Brand Name: CELL SAVER® ELITE® PLUS AUTOTRANSFUSION SYSTEM
• Common Device Name: CS ELITE PROCESSING KIT, 125ML
• Manufacturer (Section D): HAEMONETICS, INC.; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS, INC.; 125 summer street; boston MA 02110
• Manufacturer Contact: brenda bruyere ; 125 summer street; boston, MA 02110
• MDR Report Key: 14346133
• Report Number: 1219343-2022-00025
• Device Sequence Number: 5220370
• Product Code: CAC
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)240602(10)0621011
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/04/2022

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 Expiration Date: 06/02/2024
• Device Model Number: CSE-P-125
• Device Lot Number: 621011
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown