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	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information was provided at this time.A photo was provided of the bowl from the cell saver elite set which confirmed a leakage at the top header shield ports of the bowl.The bowl is not available for return.Without physical sample provided for evaluation the root cause could not be determined.
Event or Problem Description
On (b)(6) 2020 haemonetics was notified of a fluid eruption which had occurred during a spinal procedure, utilizing the cell saver® elite® autotransfusion system and cell saver® elite set - 225ml.There was no reported impact to patients' health and no possible exposure to the techs involved in cleaning the system.

• Brand Name: CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
• Common Device Name: CS ELITE PROCESSING KIT, 225ML
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 sumer street; boston, ma
• MDR Report Key: 10317739
• Report Number: 1219343-2020-00072
• Device Sequence Number: 515741
• Product Code: CAC
• UDI-Device Identifier: 10812747016544
• UDI-Public: (01)10812747016544(17)230401(10)0420022
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/25/2020

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 Expiration Date: 04/01/2023
• Device Model Number: CSE-P-225
• Device Lot Number: 0420022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1