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

Catalog Number 1087947

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Code Available (3191)

Event Date 06/19/2019

Event Type  malfunction  

Event Description

Back check valve failed on the primary bd alaris pump infusion set.Primary was set up and running.When rn hooked up the secondary to run iv antibiotic (primary was on extender and secondary was hung high) the entire bag flowed into the primary back.Rn contacted the provider and gave the entire 500 ml bag with antibiotic to the patient.

• Brand Name: SMARTSITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 8910534
• MDR Text Key: 154885144
• Report Number: 8910534
• 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: 06/24/2019

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: Health Professional
• Device Catalogue Number: 1087947
• Device Lot Number: (10)19046497
• 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: 06/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8395 DA