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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Unspecified Blood or Lymphatic problem (4434)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hameonetics received the unit for evaluation.A submersion leak test was performed and a small micro leak was identified on a section of the left tubing port.
Event or Problem Description
On march 15 2021, haemonetics was notified of a blood leak of approximately 400ml which occurred during a procedure in france, utilizing the cell saver® 5 autologous recovery system and cell saver® 5 set - 225ml.The blood leak occurred at the connection between the transfusion bag and the tubing.The procedure was discontinued, patient refused blood transfusion although hemoglobin threshold justified it.The patient experienced longer convalescence and hospitalization due to the incident.

• 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: 11670400
• Report Number: 1219343-2021-00109
• Device Sequence Number: 11723366
• Product Code: CAC
• UDI-Device Identifier: 30812747016548
• UDI-Public: (01)30812747016548(17)230603(10)0620022
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/15/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/03/2023
• Device Model Number: CSE-P-225
• Device Lot Number: 0620022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 04/15/2021
• 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: Hospitalization