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

Model Number PX3X3284C

Patient Problem Insufficient Information (4580)

Event Date 07/17/2023

Event Type  malfunction  

Event Description

During a heart set up and zeroing invasive lines it was noted that the transducer set would not flow fluid with pressure.Three sets were used before finding a non-defective set.Edwards lifesciences, ref # (b)(4), lot # 65007202, exp # 2025-04-13, manufacture # 2023-04-14.

• 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: 17445658
• MDR Text Key: 320257382
• Report Number: 17445658
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/18/2023

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: Health Professional
• Device Model Number: PX3X3284C
• Device Catalogue Number: PX3X3284C
• Device Lot Number: 65007202
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/18/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1