MAUDE Adverse Event Report: HAEMONETICS, INC. CELL SAVER® ELITE® PLUS AUTOTRANSFUSION SYSTEM; CELL SAVER ELITE SET - 125ML

Model Number	CSE-P-125
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2022, haemonetics confirmed a bowl crack via a photograph submitted by the customer.Although there was no injury or harm to patient or user, past reporting (1219343-2020-00001-01) indicates this particular malfunction on a similar device has been associated with a reported death event.The investigation of 12143-2020-00001-01 indicated the inner core of the bowl malfunctioned via a crack but did not cause or contribute to the reported incident according to the surgeon that performed the surgery.Haemonetics decided to conservatively report inner core cracks that are confirmed by manufacturing due to the event in that report.
Event or Problem Description
On (b)(6) 2022, haemonetics was notified of the following: bowl failure on a 125 elite bowl, the failure occurred after a number of bowls processed, this time on the fifth bowl.Again the warning is a "long empty cycle" followed by fluid in the bottom cavity of the bowl, despite the bowl being empty.This time it was picked up before the bowl split and spilt into the centrifuge.This required a change out of the processing kit mid way during a procedure in australia utilizing the cell saver® elite® autotransfusion system and cell saver® elite set 125ml.There was no reported impact to the health of the patient or user.

• Brand Name: CELL SAVER® ELITE® PLUS AUTOTRANSFUSION SYSTEM
• Common Device Name: CELL SAVER ELITE SET - 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: 13638564
• Report Number: 1219343-2022-00012
• Device Sequence Number: 2186961
• Product Code: GKT
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)240602(10)0621011
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

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: 02/06/2024
• Device Model Number: CSE-P-125
• Device Lot Number: 0621011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• 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
• Patient Sex: Unknown