MAUDE Adverse Event Report: EDWARDS LIFESCIENCES TRUWAVE VAMP PLUS; PRESSURE MONITORING SET

Model Number	PXVP2284AT3
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before use with a pressure monitoring set that there was a tube that became detached.The facility is unable to indicate the location of the tubing that became detached.The user had tightened all the connections.There is no patient harm or injury.
Additional Manufacturer Narrative
The device was discarded at the facility and is not available to be returned.The lot number is unknown; therefore, the device history record review is unable to be completed.An engineering evaluation has been initiated to assess for any manufacturing related processes which could be correlated to the complaint.Additional product code, kra.Additional 510k numbers, k181684 and k896819.

• Brand Name: TRUWAVE VAMP PLUS
• Common Device Name: PRESSURE MONITORING SET
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 17200 laguna canyon road; irvine CA 92618
• Manufacturer (Section G): EDWARDS LIFESCIENCES DOMINICAN REPUBLIC; parque industrial de itabo; carr sanchez km 18.5
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon road; irvine, CA 92618 ; 9492017706
• MDR Report Key: 21894120
• Report Number: 2015691-2025-03175
• Device Sequence Number: 15494315
• Product Code: DXO
• UDI-Device Identifier: 07460691950436
• UDI-Public: (01)07460691950436
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K142749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2025

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
• Operator of Device: Health Professional
• Device Model Number: PXVP2284AT3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown