MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE AUTOTRANSFUSION SYSTEM; CS ELITE PROCESSING KIT, 225ML

Model Number	CSE-P-225
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A haemonetics field service engineer evaluated the cell saver 5 autologous blood recovery system.The haemonetics field service engineer performed functional check and pinch valve occlusion, the system passed functional check, pinch valve occlusion check and was determined fit for use.The cell saver® elite set - 225ml sample was discarded by customer and will not be returned to haemonetics for evaluation, without the physical sample haemonetics is unable to perform further evaluation.
Event or Problem Description
On (b)(6) 2021 haemonetics was notified of an air detected early fault which occurred on cycle 1 during a procedure in the (b)(6), utilizing the cell saver 5 autologous blood recovery system and cell saver® elite set - 225ml.The fault could not be moved forward; a second machine was then used for the same patient to continue procedure.The second cell saver 5 autologous blood recovery system and cell saver® elite set - 225ml displayed a long empty fault on cycle 1 which was reported to be caused by user, bowl not being scanned and wrong bowl size selected.There was a delay in the procedure and patient had a 9-liter hemorrhage which required the patient to receive a blood transfusion.

• Brand Name: CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
• Common Device Name: CS ELITE PROCESSING KIT, 225ML
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 11549463
• Report Number: 1219343-2021-00017
• Device Sequence Number: 3830049
• Product Code: CAC
• UDI-Device Identifier: 30812747016548
• UDI-Public: (01)30812747016548(17)210227(10)0218064
• 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): Y
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/02/2021

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 Expiration Date: 02/27/2021
• Device Model Number: CSE-P-225
• Device Lot Number: 0218064
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/23/2021
• 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: Other