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

Lot Number 0621028

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 11/19/2021

Event Type  malfunction  

Event Description

Narrative from staff: the cell saver disposable bowl leaked after the start of the second run.The leak occurred underneath the support arm bowl header.

• Brand Name: CELL SAVER
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): HAEMONETICS CORPORATION; 400 wood road; braintree MA 02184
• MDR Report Key: 12975213
• MDR Text Key: 282055167
• Report Number: 12975213
• 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: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 0621028
• 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: 11/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/10/2021
• 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: 114 KG