MAUDE Adverse Event Report: HAEMONETICS CORPORATION HAEMONETICS CELL SAVER ELITE SYSTEM; APPARATUS, AUTOTRANSFUSION

Model Number CSE-E-US

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

Event Date 06/22/2023

Event Type  malfunction  

Event Description

During surgical procedure, haemonetics cell saver elite autologous blood recovery system malfunctioned when attempting to process blood to return to patient.Trouble shooting by multiple team members and assistance of company representative did not resolve the problem.The error was "effluent line failure".Manufacturer response for cell saver, haemonetics cell saver elite (per site reporter).Vendor cleared unit.

• Brand Name: HAEMONETICS CELL SAVER ELITE SYSTEM
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer st; boston MA 02110
• MDR Report Key: 17949552
• MDR Text Key: 325841052
• Report Number: 17949552
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CSE-E-US
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2023
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15695 DA
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: White