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

Model Number CSE-P-125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypovolemia (2243)

Event Date 11/07/2021

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 286356185
• Report Number: 1219343-2021-00148
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)240111(10)0421026
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K120586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CSE-P-125
• Device Lot Number: 0421026
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention