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

Model Number 2426-0500

Device Problem Material Separation (1562)

Patient Problem Blood Loss (2597)

Event Date 08/25/2020

Event Type  malfunction  

Event Description

Tubing came apart at a fused area during medication infusion.Iv pump tubing pulled apart at a connection that should be factory sealed.In this case blood backed up the line and into the bed.

• Brand Name: ALARIS PUMP MODULE SMARTSITE 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: 10676793
• MDR Text Key: 211257559
• Report Number: 10676793
• 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: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• 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: 10/12/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1