MAUDE Adverse Event Report: SORIN GROUP/LIVANOVA LIVANOVA; NEONATAL ARTERIAL FILTER

Model Number 075104800

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Neonatal arterial filter leaking from seam prior to initiating bypass.Crack in filter was found on bottom corner.

• Brand Name: LIVANOVA
• Type of Device: NEONATAL ARTERIAL FILTER
• Manufacturer (Section D): SORIN GROUP/LIVANOVA
• MDR Report Key: 6519606
• MDR Text Key: 73785087
• Report Number: MW5069288
• Device Sequence Number: 1
• Product Code: DTM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 075104800
• Device Lot Number: 1632800054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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