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

Model Number 2420-0007

Device Problem Failure to Infuse (2340)

Patient Problem No Information (3190)

Event Date 05/04/2018

Event Type  malfunction  

Event Description

Iv tubing would not prime.Fluid would fill chamber but would not travel down tubing. brought up in safety huddle, 2 other nurses chimed in that this has also been a problem for them on other units.

• 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: 7665869
• MDR Text Key: 113306465
• Report Number: 7665869
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2018,06/28/2018

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: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2018
• Date Report to Manufacturer: 07/06/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1