MAUDE Adverse Event Report: SORIN GROUP BRAT 2 250 ML; AUTOLOGUS BLOOD RECOVERY

Catalog Number 007214100

Device Problems Fluid/Blood Leak (1250); Defective Device (2588)

Patient Problem No Information (3190)

Event Date 01/14/2014

Event Type  malfunction  

Event Description

Brat 2 250 autologous blood processing bowls gasket leaked during processing of blood intraoperatively.Preventive maintenance company called in to check all brat at machines.All 4 checked out as good to go.Problem of bowl gasket leak continued to occur during surgery.All new unopened sterile bowls sent back to the sorin group in 2013 with replacements of a different lot stocked as replacement.Problem persist.Sorin called and i reported that the bowl gaskets were failing in 50% of the bowls.Sent defective bowls to sorin.

• Brand Name: BRAT 2 250 ML
• Type of Device: AUTOLOGUS BLOOD RECOVERY
• Manufacturer (Section D): SORIN GROUP; arvada CO 80004 359
• MDR Report Key: 3588948
• MDR Text Key: 4186449
• Report Number: MW5033933
• Device Sequence Number: 1
• Product Code: MDP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 007214100
• Device Lot Number: 1306120058
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1