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

Catalog Number 10879047

Device Problems Crack (1135); Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/14/2020

Event Type  malfunction  

Event Description

The nurse stated that when she put in tubing into the alaris pump, it kept alarming and making large volumes of air in the tubing.When she removed the tubing from the pump to inspect it, she noticed a crack in the tubing above the blue plastic piece.

• Brand Name: ALARIS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 9752982
• MDR Text Key: 180851377
• Report Number: 9752982
• 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: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10879047
• Device Lot Number: (10) 19096345
• 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: 01/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26280 DA