MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC TRUWAVE; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PX12N

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 09/27/2020

Event Type  malfunction  

Event Description

Found the pt's uac leaking on transducer tubing.Leak found at connection site right after stopcock.

• Brand Name: TRUWAVE
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 10747335
• MDR Text Key: 213433359
• Report Number: 10747335
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/15/2020

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: No Information
• Device Model Number: PX12N
• Device Catalogue Number: PX12N
• Device Lot Number: 6321110
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30 DA