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

Model Number	CSE-EW-UK
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A haemonetics field service engineer evaluated the data log files from the cell saver elite system used in the procedure.Data showed that the device functioned correctly as there were no early trip to wash events caused by the device.A dhr review was performed and the product met all specifications during final manufacturing tests.There are no corrective actions or non-conformances related to this event.The disposables used during the procedure were not returned for evaluation.There is no evidence to suggest that the event was related to the device used during the procedure.There was no report of patient harm reported in this event.
Event or Problem Description
On (b)(6) 2022, haemonetics was notified of "failure to empty 3rd bowl into rbc bag x 2, new bowl set loaded.4th bowl with new bowl set also failed to empty.Blood from both bowls discarded.Donor transfusion received / quantity: none received (confirmed (b)(6) 2021).Cell salvage blood re-infused / volume: 221 ml re-infused (x 2 full bowls discarded) - approx another 225 ml" during a procedure using a cell saver® elite® plus autotransfusion system and cell saver® elite set-125m in the united kingdom.It was decided to communicate an initial mdr report due to potential procedure delay.No harm to the patient was reported in this event.

• Brand Name: CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM
• Common Device Name: CELL SAVER ELITE +, UK
• 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: 14753976
• Report Number: 1219343-2022-00031
• Device Sequence Number: 6153485
• Product Code: CAC
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)240602(10)0621011
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CSE-EW-UK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown