MAUDE Adverse Event Report: CAREFUSION 303, INC. EXTENSION SET SMALLBORE TUBING 1.2 MICRON LOW PROTEIN BINDING FILTER; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 20129E

Device Problem Leak/Splash (1354)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 07/09/2018

Event Type  malfunction  

Event Description

Iv fluid noted on floor under lipid line.Line leaking below or around lipid filter and tpn/pt meds were backing up lipid line and dripping on floor.Infant meds included morphine gtt, dopamine, dobutamine, and precedex.Noted to be more agitated, but pressure remain stable.Stopped lipids and replaced tubing without a filter.Cleared tpn tubing to remove any excess backup of meds and started fluids.Abp slightly increased after restarting.

• Brand Name: EXTENSION SET SMALLBORE TUBING 1.2 MICRON LOW PROTEIN BINDING FILTER
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC. ; san diego CA
• MDR Report Key: 7689301
• MDR Text Key: 114279335
• Report Number: MW5078389
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20129E
• Device Catalogue Number: 20129E
• Device Lot Number: H37020129E1B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 DA