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

Model Number 2426-0500

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 04/05/2022

Event Type  malfunction  

Event Description

The rn was attempting to infuse medication, and the pump continually stated "air in line" after multiple attempts to trouble shoot with multiple rns.Once the tubing was changed, the infusion ran smoothly.The tubing was from pharmacy, and they were unsure of the exact tubing packaging it came from.

• Brand Name: ALARIS PUMP INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 14218343
• MDR Text Key: 290171022
• Report Number: 14218343
• 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: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Device Lot Number: 21103419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/11/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10585 DA
• Patient Sex: Male