MAUDE Adverse Event Report: SORIN GROUP SORIN; HEART LUNG BYPASS MACHINE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 02/04/2016

Event Type  Death  

Event Description

During the cabg/avr procedure in the operating room there was air pumping into the arterial line shortly after initiation of coronary artery bypass.Lines were disconnected and de-aired and pt was reconnected to the bypass machine using same tubing/machine/cannulas.The pt was stable for remainder of case and transported to the surgical icu where he later passed.At this time the event is still under investigation as to the exact root cause.Oxygenator/reservoir were saved and will be sent to mfr for evaluation as well.

• Brand Name: SORIN
• Type of Device: HEART LUNG BYPASS MACHINE
• Manufacturer (Section D): SORIN GROUP; arvada CO 80004
• MDR Report Key: 5445153
• MDR Text Key: 38517854
• Report Number: MW5060251
• Device Sequence Number: 1
• Product Code: DTQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 81 YR
• Patient Weight: 80