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

Lot Number 15126211

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2016

Event Type  malfunction  

Event Description

Iv pump beeping occluded.When they opened the chamber the iv tubing had a large firm bubble noted.No other medications were given through the tubing.

• Brand Name: SMARTSITE INFUSION SET
• Type of Device: IV FLUID TUBING
• Manufacturer (Section D): CAREFUSION
• MDR Report Key: 5398045
• MDR Text Key: 37088559
• Report Number: MW5059761
• Device Sequence Number: 1
• Product Code: FPA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/22/2016

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 Lot Number: 15126211
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: (B)(4)WAS INFUSING