MAUDE Adverse Event Report: CAREFUSION SMARTSITE; INFUSION SET

Model Number 2420-0500

Device Problems Air Leak (1008); Occlusion Within Device (1423); Device Displays Incorrect Message (2591)

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

Event Date 10/26/2017

Event Type  malfunction  

Event Description

Iv tubing primed, when placed in ivac and set to run, alarmed occluded on pt side.On examination, the line to determine area occlusion, large water bubble noted in rubber tubing in chamber.

• Brand Name: SMARTSITE
• Type of Device: INFUSION SET
• Manufacturer (Section D): CAREFUSION
• MDR Report Key: 6989953
• MDR Text Key: 90777350
• Report Number: MW5073046
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Model Number: 2420-0500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1