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 01/30/2014

Event Type  Other  

Event Description

Sorin group received a user medwatch report indicating the cell saver machine stopped working.The medwatch report stated typed and cross-matched blood had to be substituted.

Manufacturer Narrative

Sorin group received a user medwatch report indicating the cell saver machine stopped working.The medwatch report stated type and cross-matched blood had to be substituted.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.Medwatch user report number: 3600510000-2014-8015.

• 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 west 65th way; arvada CO 80004
• Manufacturer Contact: cheri voorhees, mgr. ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 3902397
• MDR Text Key: 4429068
• Report Number: 1718850-2014-00190
• 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
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/02/2014

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2014
• Initial Date FDA Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 70 YR
• Patient Weight: 107