MAUDE Adverse Event Report: SORIN GROUP USA, INC. BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM; APPARATUS, AUTOTRANSFUSION

Catalog Number 007320000

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2014

Event Type  Other  

Event Description

Sorin group received a report that the brat2 autologous blood salvage system shut down by itself during a procedure.There was no report of pt injury.

Manufacturer Narrative

The investigation is ongoing.A follow up report will be sent when the investigation is complete.

Manufacturer Narrative

Sorin group received a report that the brat2 autologous blood salvage system shut down by itself during a procedure.There was no report of patient injury.A sorin group service representative was dispatched to the facility to investigate.While one site, the service representative was able to reproduce the issue and found that it was caused by a problem with the process interface board.The board was replaced and subsequent testing confirmed that the unit was functioning properly.It was later reported that this unit has been taken out of service and is no longer in use by the facility.The replaced circuit board was returned to sorin group usa for evaluation and simulated use testing confirmed the reported issue.The returned circuit board will be scrapped as a precaution.The brat2 machine is no longer being manufactured and no trend has been identified, therefore no further actions are deemed necessary at this time.

• Brand Name: BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 west 65th way; arvada CO 80004
• Manufacturer (Section G): SORIN GROUP USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: carrie wood ; 14401 w 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 4208972
• MDR Text Key: 5043247
• Report Number: 1718850-2014-00384
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K933625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2014

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: Health Professional
• Device Catalogue Number: 007320000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2014
• Initial Date FDA Received: 10/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 109