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

Model Number CSE-P-125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypovolemia (2243)

Event Date 02/13/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 291293260
• Report Number: 1219343-2022-00025
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)240602(10)0621011
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K120586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CSE-P-125
• Device Lot Number: 621011
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other