MAUDE Adverse Event Report: HAEMONETICS, INC. CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM; CELL SAVER ELITE+, UK

Model Number CSE-EW-UK

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Blood or Lymphatic problem (4434)

Event Date 11/03/2021

Event Type  Injury  

Manufacturer Narrative

There was no reported detrimental impact on the patient or their health status.Haemonetics is reporting this incident based on the amount of blood lost.The device was not evaluated, therefore, a cause could not be established.

Event Description

On (b)(6) 2021, haemonetics was notified of an early wash trigger which occurred during a procedure in the (b)(6), utilizing the cell saver elite.There was an estimated blood loss of 700 ml and 109 ml (full bowl) was re-infused to the patient.There was no reported harm to the patient as a result of this incident.

• Brand Name: CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM
• Type of Device: CELL SAVER ELITE+, UK
• 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: 13025311
• MDR Text Key: 282398073
• Report Number: 1219343-2021-00155
• Device Sequence Number: 1
• Product Code: CAC
• 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,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CSE-EW-UK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2019
• 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): Life Threatening