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

Device Problems Air Leak (1008); Break (1069); Device Operates Differently Than Expected (2913)

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

Event Date 01/02/2017

Event Type  malfunction  

Event Description

The tubing ran dry, so we attempted to back-prime tubing.During back priming process (line unclamped), the tubing formed a bubble in the portion where line is placed into iv pump.The rn then removed the tubing since it was not working properly.As tubing was removed, it broke in half.

• Brand Name: SMARTSITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 6306834
• MDR Text Key: 66684556
• Report Number: 6306834
• 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: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: QBY
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1