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

Model Number 2423-0007

Device Problems Break (1069); Material Rupture (1546)

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

Event Date 08/21/2020

Event Type  malfunction  

Event Description

(b)(6) y/o female with history of coronary artery disease (cad).Admitted for left heart catheterization.During the procedure, the iv was running in the pump, the tubing of the infusion set began to bulge and eventually ruptured.The tubing broke in half at that point.The appearance of the tubing from the break site is cloudy and larger in size.No known harm to patient.Please see attached pictures.Identified reference numbers represent original.

• 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: 10513972
• MDR Text Key: 206311929
• Report Number: 10513972
• 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: 08/25/2020

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: 2423-0007
• Device Catalogue Number: 2423-0007
• 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: 08/25/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Weight: 82