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

Model Number 2426-0007

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Gas/Air Leak (2946)

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

Event Date 02/24/2022

Event Type  malfunction  

Event Description

To prepare for patient's scheduled infusion we primed the infusion pump tubing set with ogivri, medication for infusion.Once the iv tubing was placed into the alaris pump and the pump was started, the pump immediately alarmed with an "air in the line" notification.Upon further assessment a small bubble was located in the tubing located inside the channel door.The channel door was closed to prepare to remove the air bubble, but it was immediately noticed that a small amount of fluid was at the blue plastic portion superior to the pump segment of the tubing.When the door was opened to assess further the fluid had a short stream of medication that was expressed from a very small hole located at the portion of the tube where the top of the pump segment meets with the blue plastic part that sets at the top of the channel door.Immediately the medication was removed and the iv tubing replaced, leaving the fluid in the faulty tubing to waste as the hole is a break in the sterile line.

• 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: 13839270
• MDR Text Key: 287548511
• Report Number: 13839270
• 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: 02/28/2022,02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 21096235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2022
• Event Location: Other
• Date Report to Manufacturer: 03/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Female
• Patient Race: White