MAUDE Adverse Event Report: HAEMONETICS, INC. CELL SAVER® ELITE® PLUS AUTOTRANSFUSION SYSTEM; CS ELITE PROCESSING KIT, 125ML,

Model Number	CSE-P-125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypovolemia (2243)
Date of Event	11/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient was reported to have no adverse reaction for this event; however, a blood transfusion was required due to the cell saver incident.A photograph was provided by the customer and was observed by haemonetics to have a fat-like clot inside the harness line.The cell saver® elite set - 125ml sample was not returned to haemonetics; without the physical sample, haemonetics is unable to confirm or determine a root cause.Disposable lot #0421026 was manufactured according to approved procedures and met all specifications for release, with no noted manufacturing deviations, nonconformances or capas that would have contributed to the reported incident.
Event or Problem Description
On (b)(6) 2021, haemonetics was made aware of an incident involving a cell saver® elite® plus autotransfusion system and cell saver® elite set-125ml.The device was in fat reduction mode, gas and qc sent.Hct came back at 0.114 so very dilute and was not transfused to the patient.The cell salvaged blood was discarded and the patient required an intra-operative rbc tx due to the loss of cell salvaged blood.

• Brand Name: CELL SAVER® ELITE® PLUS AUTOTRANSFUSION SYSTEM
• Common Device Name: CS ELITE PROCESSING KIT, 125ML,
• 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: 12927649
• Report Number: 1219343-2021-00148
• Device Sequence Number: 14844988
• Product Code: CAC
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)240111(10)0421026
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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: 04/06/2024
• Device Model Number: CSE-P-125
• Device Lot Number: 0421026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown