MAUDE Adverse Event Report: LIPID FILTER; FILTER, INFUSION LINE

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2018

Event Type  Injury  

Event Description

We had a chipped lipid filter make it the newborn icu.When the rn was priming the line, lipids leaked at the connection port.When examining the line, very small chip was identified that it was the culprit.Lipids were stopped that night so didn't reach the pt's picc line.Pictures of products available.

• Brand Name: LIPID FILTER
• Type of Device: FILTER, INFUSION LINE
• MDR Report Key: 8125108
• MDR Text Key: 129300993
• Report Number: MW5081786
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention