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

Catalog Number 2420-0007

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 11/18/2015

Event Type  malfunction  

Event Description

Iv pump repeatedly alarming occluded; restarted iv pump.Iv pump alarmed, safety clamped iv tubing and opened iv pump channel.Iv tubing had a large bubble just under the blue piece that connects to the pump channel.

• Brand Name: SMARTSITE PRIMARY INFUSION IV SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 5403767
• MDR Text Key: 37293466
• Report Number: 5403767
• 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: 12/29/2015,01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 2420-0007
• 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: 12/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 57