MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM; CSE-P-125

Model Number	CSE-P-125
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Unspecified Blood or Lymphatic problem (4434)
Date of Event	02/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A haemonetics field service engineer evaluated the cell saver® elite® autotransfusion system and downloaded the procedure events data.The system was deemed to fit to use with no device malfunctions found.The cell saver® elite set - 125ml was received for manufacturing evaluation, blood was identified in the inner core and cracks were also identified in the inner core.
Event or Problem Description
On february 08 2021, haemonetics was notified of a long empty alert on cycle 1 of a vascular procedure in (b)(6), utilizing the cell saver® elite® autotransfusion system and cell saver® elite set - 125ml system.During procedure fluid was also detected in the centrifuge well and in the waste bag.A new set was used to continue procedure, fluid detected in centrifuge was again present.Due to incident transfusion was necessary, patients health status was reported as fine.

• Brand Name: CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM
• Common Device Name: CSE-P-125
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 11443258
• Report Number: 1219343-2021-00012
• Device Sequence Number: 19852738
• Product Code: CAC
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)230320(10)0320055
• 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): 02/08/2021

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: 03/20/2023
• Device Model Number: CSE-P-125
• Device Lot Number: 0320055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/09/2021
• 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