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

Model Number CSE-P-225

Device Problem Fluid/Blood Leak (1250)

Patient Problem Unspecified Blood or Lymphatic problem (4434)

Event Date 02/25/2021

Event Type  Injury  

Manufacturer Narrative

Hameonetics received the unit for evaluation.A submersion leak test was performed and a small micro leak was identified on a section of the left tubing port.

Event Description

On march 15 2021, haemonetics was notified of a blood leak of approximately 400ml which occurred during a procedure in france, utilizing the cell saver® 5 autologous recovery system and cell saver® 5 set - 225ml.The blood leak occurred at the connection between the transfusion bag and the tubing.The procedure was discontinued, patient refused blood transfusion although hemoglobin threshold justified it.The patient experienced longer convalescence and hospitalization due to the incident.

• 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: 11670400
• MDR Text Key: 245557718
• Report Number: 1219343-2021-00109
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 30812747016548
• UDI-Public: (01)30812747016548(17)230603(10)0620022
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2023
• Device Model Number: CSE-P-225
• Device Lot Number: 0620022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Date Manufacturer Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2020
• 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): Hospitalization