MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE AUTOTRANSFUSION SYSTEM; CS ELITE PROCESSING KIT, 225ML

Model Number CSE-P-225

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Blood or Lymphatic problem (4434)

Event Date 09/02/2021

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.Haemonetics is reporting based on the amount of blood lost as well as the need for a transfusion.The long empty alarm triggered on the device which stopped the procedure, the device worked as expected.Haemonetics reviewed the data in the history log of the device which showed multiple incorrect operator actions.The disposable sample was discarded, with no sample available for investigation haemonetics is unable to perform an evaluation.

Event Description

On (b)(6) 2021 haemonetics was notified of a long empty alarm with waste contamination which occurred during a procedure in the united kingdom, utilizing the cell saver® 5 autologous recovery system and cell saver® 5 set - 225ml.The cell salvage blood was reinfused and approximately 600ml was discarded.Donor transfusion was received.

• Brand Name: CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
• Type of Device: CS ELITE PROCESSING KIT, 225ML
• 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: 12541506
• MDR Text Key: 273616740
• Report Number: 1219343-2021-00128
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 10812747016544
• UDI-Public: (01)10812747016544(17)210904(10)0918019
• 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: 10/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2021
• Device Model Number: CSE-P-225
• Device Lot Number: 0918019
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2018
• 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): Other
• Patient Age: 39 YR