MAUDE Adverse Event Report: SORIN SORIN; CELL SAVER

Model Number 75221

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2014

Event Type  malfunction  

Event Description

During open heart procedure, sorin cell saver equipment in use with 250 ml bowl, blood exploded in saver's chamber.Blood contained to device with leakage to outside.Surgical procedure completed without adverse event.

• Brand Name: SORIN
• Type of Device: CELL SAVER
• Manufacturer (Section D): SORIN; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 4076465
• MDR Text Key: 4858286
• Report Number: MW5038094
• Device Sequence Number: 1
• Product Code: CAC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/27/2014

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 Model Number: 75221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1