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

Model Number 2420-0500

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2018

Event Type  malfunction  

Event Description

Found primary tubing with small hole near top of silicon portion that is inserted into the pump channel.Liquid from heparin drip was leaking onto the floor from pump channel.The 3rd time i have found this issue with primary tubing having small hole in same location.The patient did not see any negative impact.

• Brand Name: ALARIS, SMART SITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 7605181
• MDR Text Key: 111195499
• Report Number: 7605181
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203012448
• UDI-Public: 37613203012448
• 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: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• 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: 06/05/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2018
• 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