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

Model Number 10012866

Device Problem Air Leak (1008)

Patient Problem No Information (3190)

Event Date 10/01/2017

Event Type  malfunction  

Event Description

When using lipid filters, we have had air in the filter or distal to the lipid filter.

• Brand Name: ALARIS EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 120 s. state college, suite 100; brea CA 92821
• MDR Report Key: 7230402
• MDR Text Key: 98662794
• Report Number: 7230402
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 10012866
• Device Catalogue Number: 10012866
• Other Device ID Number: EXTENSION SET 1.2 MICRON LOW
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/16/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: TUBING MAY HAVE BEEN Y'D WITH TPN OR FLUIDS MOST L
• Patient Weight: 2