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

Model Number CSE-P-125

Device Problem Insufficient Information (3190)

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

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

Haemonetics sent a field service engineer to evaluate the cell saver® elite® autotransfusion system, system was determined to be fit for use.The log files for the system were downloaded, there was no problem found with firmware/hardware/software.The cell saver® elite set - 125ml sample was not returned to haemonetics, customer confirmed that smaple was discarded.Customer stated that there were no visible cracks or leaks observed, without physical sample haemonetics is unable to confirm or determine root cause.

Event Description

On (b)(6) 2020 haemonetics was notified of a long empty and air detected error alarm which was displayed on the 7th cycle of the empty phase during a procedure in the (b)(6), utilizing the cell saver® elite® autotransfusion system and cell saver® elite set - 125ml.Patient required allogeneic red blood cells due to the loss of autologous blood and pause in procedure.

• Brand Name: CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM
• Type of Device: CS ELITE PROCESSING KIT, 125ML
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer Contact: janice kiser ; 125 summer street; boston, MA 02110
• MDR Report Key: 10927332
• MDR Text Key: 218926978
• Report Number: 1219343-2020-00124
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)230216(10)0220056
• 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
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/09/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2023
• Device Model Number: CSE-P-125
• Device Lot Number: 0220056
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention