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

Model Number 2426-0007

Device Problems Stretched (1601); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 02/10/2023

Event Type  malfunction  

Event Description

Alaris pump alarmed stating occlusion downstream.Nurse checked patency of iv which was normal.When she opened the channel, the iv tubing had stretched creating a large bubble.

• 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: 16416394
• MDR Text Key: 309983539
• Report Number: 16416394
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• 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
• Device Lot Number: 22099199
• 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: 02/14/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20805 DA
• Patient Sex: Male