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

Model Number CSE-P-125

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 291296021
• Report Number: 1219343-2022-00012
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)240602(10)0621011
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K120586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2024
• Device Model Number: CSE-P-125
• Device Lot Number: 0621011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• 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