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

Model Number CSE-P-225

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 06/26/2023

Event Type  malfunction  

Event Description

From staff: tubing cracked causing blood to leak into cell saver machine.Manufacturer response for apparatus, autotransfusion, haemonetics cell saver elite system (per site reporter).Working with [redacted name], executive clinical specialist, who is working on sending a shipper kit so i can send back to the company.

• 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: 17331774
• MDR Text Key: 319118795
• Report Number: 17331774
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSE-P-225
• Device Catalogue Number: CSE-P-225
• Device Lot Number: 0123039
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20805 DA
• Patient Sex: Male
• Patient Weight: 97 KG