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

Catalog Number 2420-0007

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

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

Event Date 08/17/2016

Event Type  malfunction  

Event Description

There were 3 grams of unasyn infusing when the nurse heard the iv alarm beeping.The nurse re-started the pump but the alarm continued to beep.She then opened up the chamber and noted a bubble within the tubing.She then changed the line and ordered a new bag of unasyn.There was no injury noted to the patient.

• Brand Name: SMARTSITE 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: 5892876
• MDR Text Key: 52627812
• Report Number: 5892876
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2420-0007
• 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: 08/18/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2016
• 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
• Patient Age: 69 YR