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

Model Number	PXAVMP
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Primary nurse was leveling the transducer of the arterial line, the vamp and tubing separated causing back flow of blood out of the patient.With timely intervention, the line was preserved, and patient blood loss was minimal.I was at the bedside assisting with repositioning at the time, there was no substantial pressure applied to the connection in the process of leveling the transducer and minimal manipulation of the line during movement.Another identical device was obtained and used on patient and no harm occurred from this event.

• Brand Name: TRUWAVE, VAMP
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 20532153
• Report Number: 20532153
• Device Sequence Number: 6772561
• Product Code: DXO
• UDI-Device Identifier: 00690103011494
• UDI-Public: (01)00690103011494
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2024
• Report Date (Section F): 10/04/2024

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 Model Number: PXAVMP
• Device Catalogue Number: PXAVMP
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male
• Date Report Sent to FDA: 10/04/2024