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

Catalog Number 2426-0500

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

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

Event Date 08/31/2016

Event Type  malfunction  

Event Description

Attempting to start angiomax infusion.Smartsite infusion set (ref: (b)(4)) was used.Tubing was primed clean with no air or bubbles.Placed in alaris pump.Air-in-line alarm sounded.Tubing removed from pump and reprimed.Air-in-line alarm sounded again.Tubing moved to new pump and reprimed.Air-in-line sounded again.Tubing moved to third pump and air-in-line alarm sounded again.New smartsite infusion set primed.By this time the 50ml bag of angiomax was empty.New bag of angiomax connected to tubing.Hung using same pump.Bolus and infusion started without difficulty.One bag of angiomax was wasted, approximately $800.00 and procedure was delayed for approximately 5 minutes trying to get angiomax infusion started.Package and tubing saved.

• Brand Name: SMART SITE INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 5982876
• MDR Text Key: 55795068
• Report Number: 5982876
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/01/2016
• Device Catalogue Number: 2426-0500
• Device Lot Number: 16067921
• 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: 09/12/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2016
• 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
• Treatment: SMART PUMP
• Patient Age: 77 YR
• Patient Weight: 114