MAUDE Adverse Event Report: BRAUN BLUE FILTER (LIPID FILTER); LIPID INFUSION FILTER

Model Number FE1212F

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2017

Event Type  malfunction  

Event Description

Lipid filter was primed along with the rest of the tpn and il line, was connected to pt's uvc.Once connected to uvc filter started empty cause a large air bubble in the line.Filter was replaced with another filter with the same lot number, which also emptied out and caused another air bubble.Second filter was replaced with a filter with the different lot number, issue resolved.

• Brand Name: BLUE FILTER (LIPID FILTER)
• Type of Device: LIPID INFUSION FILTER
• Manufacturer (Section D): BRAUN
• MDR Report Key: 6809673
• MDR Text Key: 83368393
• Report Number: MW5071727
• 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: Other
• Type of Report: Initial
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FE1212F
• Device Lot Number: 0061569483
• Is the Reporter a Health Professional?: No
• 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: 1 DA