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

Model Number 10015012

Device Problem Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2021

Event Type  malfunction  

Event Description

Pump reading "air in line" tpn leaking.

• Brand Name: ALARIS, SMARTSITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 11854910
• MDR Text Key: 251673602
• Report Number: 11854910
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/05/2021,04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10015012
• Device Catalogue Number: 10015012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2021
• Date Report to Manufacturer: 05/20/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1