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

Model Number CSE-P-225

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

Patient Problem Death (1802)

Event Date 05/20/2020

Event Type  Death  

Manufacturer Narrative

Limited patient information was provided at this time.Haemonetics sent a field service engineer to evaluate the cell saver® elite® autotransfusion system in order to check for any faults, the machine was found to meet specifications and did not have any defects which required repair.There was no evidence of a device malfunction found.

Event Description

On june 10 2020 haemonetics was notified of a patient fatality which had occurred within 48 hours of the patients' procedure, utilizing the cell saver® elite® autotransfusion system and cell saver® elite set - 225ml.A long empty error message was displayed on the 6th cycle of the return process, cycles were continued till end of operation.A total blood volume of 1748ml was processed and there was no reported impact to patients' health.The cause of death was reported to be unknown, a copy of the coroner's report was not available at this time.

Manufacturer Narrative

B5: following section was updated to include all available information.

Event Description

Multiple error messages were displayed on the system: long empty, air detected early, and partial bowl.

• 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
• MDR Report Key: 10252297
• MDR Text Key: 198161650
• Report Number: 1219343-2020-00064
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 30812747016357
• UDI-Public: (01)30812747016357
• Combination Product (y/n): N
• PMA/PMN Number: K120586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CSE-P-225
• Device Lot Number: 0618031
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death