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

Model Number 2420-0007

Device Problems Excess Flow or Over-Infusion (1311); Pumping Problem (3016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2021

Event Type  malfunction  

Event Description

I was hanging calcium chloride as a secondary medication.I programmed the pump to infuse over the standard 1 hour.I then started to do other task in my patient's room.I then took a glance at the iv pump and noticed that my calcium chloride had finished being infused but it had only been a few minutes since i had hung the infusion.I told my charge nurse and we agreed i needed to change out the iv pump channel and brain.I then proceed to hang magnesium sulfate as another secondary medication.I programmed the pump to infuse over the standard 1 hour.I watched the infusion start and noticed that it was dripping in faster than normal.I also noticed that even when the medication was paused, the secondary medication (magnesium sulfate) was still continuing to drip in.At this time i clamped the secondary tubing.I then changed out the tubing and secondary tubing and restarted the medications.The medication started to infuse correctly.

• 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: 12827754
• MDR Text Key: 280887522
• Report Number: 12827754
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: (01)07613203021012(17)20240625
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/21/2021

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 Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: (10) 21066323
• 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: 10/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1