MAUDE Adverse Event Report: EDWARDS LIFESCIENCES TRUE WAVE VAMP; PRESSURE MONITORING KIT

Model Number	PXAVMP
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested to be returned but has not yet arrived.Once it has arrived and the product evaluation completed the findings will be submitted in a supplemental report.The device history record review is pending, once the results are available, they will be submitted in a supplemental report.Additional product code dxo.
Event or Problem Description
It was reported that there was a failure with a pressure monitoring kit.The tubing on the device broke and became disconnected on the patient side of the flow restrictor.This occurred during patient use.There was no patient harm or injury.
Additional Manufacturer Narrative
There is no product evaluation results as the device was discarded and not returned.Without its return, 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.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.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.The device history record review was performed and all manufacturing inspections passed with no non conformances.
Additional Manufacturer Narrative
One dpt vamp adult kit was returned for evaluation.The reported issue that the tubing became disconnected was confirmed.As received the pressure tubing was found completely detached from the vamp reservoir bond joint.There was adhesive tape between detached tubing and the reservoir.Indications of what appeared to be bonding material were evident on the tubing bond surface area.The tubing outer diameter was measured to be 0.1415 near the point of detachment.There was no other visible damage or inconsistency found with the returned kit.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.There is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect or user error.No specific root cause could be identified.

• Brand Name: TRUE WAVE VAMP
• Common Device Name: PRESSURE MONITORING KIT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr sanchez km 18.5
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 21595050
• Report Number: 2015691-2025-01854
• Device Sequence Number: 8924842
• Product Code: KRA
• UDI-Device Identifier: 00690103011494
• UDI-Public: (01)00690103011494(17)260709(11)240709(10)65909306
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup,Followup
• Report Date (Section B): 08/11/2025

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 Expiration Date: 07/09/2026
• Device Model Number: PXAVMP
• Device Lot Number: 65909306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 04/24/2025; 07/24/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 04/25/2025; 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• 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