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

Device Problems Air Leak (1008); Break (1069); Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 03/15/2016

Event Type  malfunction  

Event Description

Patient was receiving intravenous immunoglobulin (ivig) infusion with carefusion tubing.It was noted at end of the infusion that the pump was alarming for air in line.The rn found the "blue ball" portion of the drip chamber was broken and had not functioned correctly.

• 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: 5671054
• MDR Text Key: 45722506
• Report Number: 5671054
• 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: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/23/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2016
• 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