MAUDE Adverse Event Report: CAREFUSION 303, INC. SMARTSITE INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2420-0500

Device Problems Air Leak (1008); Device Displays Incorrect Message (2591)

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

Event Date 02/23/2016

Event Type  malfunction  

Event Description

There was an "air in line" tubing error with carefusion tubing.The iv tubing was changed per policy (routine change).Previous tubing was infusing without any problems.When new tubing was inserted into channel, air in line error started alarming.We went through 3 alaris pump channels without any luck.Used a new carefusion iv package and it worked on the first try on one of the channels that previously would not allow the other drip run.Total time to trouble shoot this was 27 minutes.The problem with this delay was it caused interruptions in the fentanyl drip that is being used for sedation while on the ventilator.I was almost to the point of running the drip on gravity just so i could properly sedate my patient.Smartsite infusion set 2420-0500.Lot # (01) 07613203012430.

• Brand Name: SMARTSITE INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa road; san diego CA 92121
• MDR Report Key: 5793614
• MDR Text Key: 49516018
• Report Number: 5793614
• 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: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Catalogue Number: 2420-0500
• Device Lot Number: 0107613203012430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/27/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR