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

Model Number 2426-0007

Device Problem Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 01/23/2021

Event Type  malfunction  

Event Description

This alaris pump module smartsite infusion set was used on an alaris pump that was infusing pre-filter saline into the arterial chamber of the dialysis circuit (to help prevent the dialysis circuit from clotting off).Registered nurse noticed that the arterial chamber was losing its volume and air was infusing into that chamber from the most distal y-site port on the tubing.The prefilter saline was infusing at 200ml per hour, but more air than saline was infusing into that chamber.That port had never been accessed.We disconnected the tubing, primed it through with saline once again, and after it was hooked up, it infused air immediately through that same port.The air never reached the patient.The air bubbles in the dialysis circuit possibly caused the circuit to clot off, requiring a system change.There were 3 circuit changes during that sustained low efficiency dialysis run.

• 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: 11481951
• MDR Text Key: 239747867
• Report Number: 11481951
• 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: 03/03/2021

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: 2426-0007
• Device Catalogue Number: 2426-0007
• 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: 03/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA