MAUDE Adverse Event Report: CAREFUSION SMARTSITE INFUSION SET; IV TUBING

Catalog Number 11171447

Device Problem Air Leak (1008)

Patient Problems Death (1802); Embolus (1830)

Event Date 03/14/2016

Event Type  Death  

Event Description

Air in iv line, pt died of air embolus to brain.

• Brand Name: SMARTSITE INFUSION SET
• Type of Device: IV TUBING
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 5525682
• MDR Text Key: 41127128
• Report Number: 5525682
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 11171447
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CAREFUSION IV PUMP
• Patient Outcome(s): Death
• Patient Age: 85 YR