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.
|
|
Search Alerts/Recalls
|