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

Model Number PX12N

Device Problems No Display/Image (1183); Flushing Problem (1252)

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

Event Date 03/10/2021

Event Type  malfunction  

Event Description

New peripheral arterial line placed and could not get a waveform but still could withdraw blood.It was changed multiple items trying to troubleshoot, the stopcock was not flushing.Once a new stopcock placed, a waveform was on line/ patient's arterial line would not display a waveform on the monitor despite the ability to easily draw blood off the line.Could not flush via stopcock.Removed/exchanged stopcock and problem resolved.On inspection of device, the fluid path appears patent and the stopcock was easily flushed during the review.Lot number was unavailable so information provided below is from current stock on hand.Removed from use, available in office, pending return to manufacturer.This event had no detectable harm.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 11526517
• MDR Text Key: 241025986
• Report Number: 11526517
• 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: 03/16/2021

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: PX12N
• Device Catalogue Number: PX12N
• Device Lot Number: 63406999 (FROM CURRENT STOCK)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 4 DA