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

Model Number	VMP306
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Patient demographics unable to be obtained.The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.
Event or Problem Description
As reported, while purging this vamp jr to connect it to the central venous line, a leakage in the middle of the line at a soldered connection was noticed.At the moment of replacing the device for another one, the leaking tubing detached.As per customer's opinion, there is potential risk of air embolism, hemorrhage, and infection if the leak is not immediately detected.There was prolonged procedure time and no patient injury.The device was available for evaluation.
Additional Manufacturer Narrative
The device was received for evaluation.The report of tubing issue was confirmed, however, the tubing was found broken rather than detached.Tubing breakage could cause a leakage that implies a small amount of bodily fluid or flushing solution loss that is unlikely to result in an injury.Due to the opposing force of the routinely used pressurized saline bag, there is no potential for air entering the system.If required, the device can be exchanged without an increase in the inherent risk for infection and with minimal delay in monitoring.As such, this event is no longer considered reportable and a corrected supplemental report is being submitted.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 23741839
• Report Number: 2015691-2025-09818
• Device Sequence Number: 18667008
• Product Code: KRA
• UDI-Device Identifier: 07460691944787
• UDI-Public: (01)07460691944787(17)261201(11)250624(10)66726660
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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
• Device Model Number: VMP306
• Device Lot Number: 66726660
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown