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

Model Number CSE-P-225

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/02/2021

Event Type  Injury  

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 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
• Type of Device: CS ELITE PROCESSING KIT, 225ML
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer Contact: janice kiser ; 125 summer street; boston, MA 02110
• MDR Report Key: 11549463
• MDR Text Key: 242387184
• Report Number: 1219343-2021-00017
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 30812747016548
• UDI-Public: (01)30812747016548(17)210227(10)0218064
• 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
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2021
• Device Model Number: CSE-P-225
• Device Lot Number: 0218064
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2018
• 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