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

Model Number 20129E

Device Problems Leak/Splash (1354); Reflux within Device (1522); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 08/03/2021

Event Type  malfunction  

Event Description

I changed my uvc double lumen fluids.I then got baby up for mom to hold.I noticed blood backing up into uvc line.I then noticed lipids on the mother's leg.I quickly realized the magic filter had come apart in the middle.I clamped the part of the filter that was still attached to the uvc and no blood was lost.I rehung fluids and attached them to uvc.

• 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: 12432301
• MDR Text Key: 270155784
• Report Number: 12432301
• 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
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 20129E
• Device Catalogue Number: 20129E
• Device Lot Number: H37020129E1B
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1