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

Model Number	PXVP2X2AT3
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported during use the pressure monitoring kit tubing became disconnected.There is no additional information.There is no patient injury.The device is not available for evaluation.
Additional Manufacturer Narrative
Additional product codes include: kra catheter, continuous flush.The device was discarded; therefore, a product evaluation could not be completed.Without the return of the device, it is not possible to determine if there was damage or a defect that existed on the unit that could have contributed to the event.It is not known if any procedural factors may have contributed to the reported issue.The device history record review was not completed.As the complaint could not be confirmed, there is not sufficient evidence to determine a root cause.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: TRUWAVE, VAMP PLUS
• Common Device Name: PRESSURE MONITORING SET
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 22074778
• Report Number: 2015691-2025-04067
• Device Sequence Number: 8711564
• Product Code: DXO
• UDI-Device Identifier: 07460691950467
• UDI-Public: (01)07460691950467(17)261127(11)241127(10)66177524
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): N
• 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): 05/22/2025

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: PXVP2X2AT3
• Device Lot Number: 66177524
• 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: 04/30/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2024
• 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