MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC; CATHETER, UMBILICAL ARTERY

Lot Number 64135772

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2022

Event Type  malfunction  

Event Description

Line change was due for umbilical artery catheter (uac) fluids, the line was changed and hung at 1:20 am.Blood pressures were appropriate and line seemed to be working fine.Then blood pressure means were 66/63 and then not reading.The line was assessed and flushed and seemed to be better.The diaper cloth under the line was noted to be wet but multiple registered nurses (rns) could not figure out where the wet feeling was coming from.Line flushed again and no leaking to be noted.Line checked again at 0400 because it was not working again and leaking noted from the tubing (not at a luer lock connection site).Registered nurse called pharmacy and ordered new uac fluids.Line tubing was then changed and malfunctioning tubing saved.

• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 15629324
• MDR Text Key: 301998910
• Report Number: 15629324
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 64135772
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10 DA
• Patient Sex: Male