MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number	PXVMP184
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pressure monitoring set was received by our product evaluation laboratory for a full examination.Report of pressure tubing issue near vamp reservoir was confirmed.As received pressure tubing was found completely detached from vamp reservoir stopcock bond joint rather than broken.Indications of what appeared to be bonding material were evident on tubing bond surface area.Tubing od was measure to be within specification near the point of detachment.As received, tip section of iv spike was completely broken off.Cross surface of spike at the site of damage was rough and uneven.Broken part of the tip was not returned.No other visible damage was observed from the kit.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.A definitive root cause could not be identified.Potential contributors to the issue of tubing detached could be related to solvent bonding process or other factors such as stress applied.There are manufacturing process controls designed to prevent bonding-related issues.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.
Event or Problem Description
As reported, during use in patient, in this pressure monitoring set with vamp, the pressure tubing broke near the vamp reservoir.There was no patient injury.As per product evaluation, the pressure tubing was found completely detached from the vamp reservoir stopcock bond joint.

• Brand Name: VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• 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 ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 24615197
• Report Number: 2015691-2026-13259
• Device Sequence Number: 13219912
• Product Code: KRA
• UDI-Device Identifier: 07460691955103
• UDI-Public: (01)07460691955103(17)270616(11)250616(10)66769494
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K173586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

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: PXVMP184
• Device Lot Number: 66769494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• 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