MAUDE Adverse Event Report: HAEMONETICS, INC. CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM.; APPARATUS, AUTOTRANSFUSION

Model Number CSE-E-UK

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

The cell saver® elite® autotransfusion system was evaluated by a haemonetics field service engineer.The device was cycled for half an hour without issue.The reported system fault could not be replicated and the system error could not be recreated.There was no device malfunction found during the evaluation.There were no other similar events found in the service record of this device.No capa or nonconformance was found related to this complaint.The device history record shows no defects during manufacturing that could be associated with the current issue.The cause of the cover lock not unlocking for a period of time cannot be established at this time as it could not be replicated during the field evaluation.

Event Description

On (b)(6) 2022, haemonetics was notified by mhra that a customer using a cell saver® elite® autotransfusion system reported "during an open abdominal aortic surgery, the cell saver machine developed a critical system fault, stopped functioning and the situation became critical for the surgical team as they were in the middle of the open aorta and required suction.The attempt to restart the cell saver did not solved the problem, it still showed the message "system fault" and did not respond to anything.The cell saver was restarted twice, which did not solve the problem.Magnetic top would not open, so we could not even take the consumables out at the point of reporting to clinical technology the collecting bowl with blood was still inside as it was impossible to take it out.About 20min later, the top was opening and we took the collection bowl with blood out." staff obtained an alternative machine in theatre allowing the surgical team to safely resume surgery.There was no reported harm to patient o user.

• Brand Name: CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM.
• Type of Device: APPARATUS, AUTOTRANSFUSION
• 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: 13440891
• MDR Text Key: 288357070
• Report Number: 1219343-2022-00008
• Device Sequence Number: 1
• Product Code: CAC
• 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: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSE-E-UK
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2017
• 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