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

Model Number	CSE-P-225
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Blood or Lymphatic problem (4434)
Date of Event	09/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.Haemonetics is reporting based on the amount of blood lost as well as the need for a transfusion.The long empty alarm triggered on the device which stopped the procedure, the device worked as expected.Haemonetics reviewed the data in the history log of the device which showed multiple incorrect operator actions.The disposable sample was discarded, with no sample available for investigation haemonetics is unable to perform an evaluation.
Event or Problem Description
On (b)(6) 2021 haemonetics was notified of a long empty alarm with waste contamination which occurred during a procedure in the united kingdom, utilizing the cell saver® 5 autologous recovery system and cell saver® 5 set - 225ml.The cell salvage blood was reinfused and approximately 600ml was discarded.Donor transfusion was received.

• Brand Name: CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
• Common Device Name: CS ELITE PROCESSING KIT, 225ML
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 12541506
• Report Number: 1219343-2021-00128
• Device Sequence Number: 1416171
• Product Code: CAC
• UDI-Device Identifier: 10812747016544
• UDI-Public: (01)10812747016544(17)210904(10)0918019
• 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
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/04/2021
• Device Model Number: CSE-P-225
• Device Lot Number: 0918019
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR