MAUDE Adverse Event Report: SORIN GROUP USA, INC. BRAT CELLSAVER MACHINE; APPARATUS, AUTOTRANSFUSION

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 01/30/2014

Event Type  malfunction  

Event Description

During closing portion of open heart surgery, the cell saver machine apparently stopped working, not allowing for use of patient's own blood.Typed and cross-matched blood had to be substituted.

• Brand Name: BRAT CELLSAVER MACHINE
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 3826180
• MDR Text Key: 4499638
• Report Number: 3826180
• Device Sequence Number: 1
• Product Code: CAC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/20/2014
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 107