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

Model Number 2420-0500

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 01/17/2024

Event Type  malfunction  

Event Description

From staff: the patients' blood pressure noted to be dropping at the start of my shift, levophed drip titrated up a few times before i noticed that there was a big wet spot on the floor below the iv tubing.I found a crack in the levophed iv tubing that was leaking all over the floor.I changed the tubing and then i was able to titrate the levophed back down.

• 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: 18684636
• MDR Text Key: 335114270
• Report Number: 18684636
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• 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: 01/31/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 65 KG