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

Model Number	PXVK0670
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/23/2025
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.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, during use in patient, in this pressure monitoring set with vamp adult the arterial line detached from the reservoir causing bleeding for the patient.Apparently, there was no tugging on the line.No further information available.There was no allegation of patient injury.The device was available for evaluation.Patient demographics unable to be obtained.
Event or Problem Description
As reported, during use in patient, in this pressure monitoring set with vamp adult the pressure tubing detached at the level of the connection with the vamp reservoir, on the dpt side.There was minimal blood loss since it was noticed immediately by the registered nurse (rn).Apparently, there was no tugging on the line.No further information available.There was no allegation of patient injury.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation) updated section b5, h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).Finally, the device was not received for evaluation.Nevertheless, images were provided for review.Based on the image evaluation, the report of "pressure tubing detached at the level of the connection with the vamp reservoir" was confirmed.One image showed an outer labeling from reported model but different lot number.Second image showed a tyvek pouch from reported model and lot number.The third image showed vamp adult reservoir and pressure tubing.Pressure tubing appeared to be completely detached from vamp reservoir.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.Corrective actions are being investigated in order to eliminate the cause of the non-conformity and prevent recurrence of this type of complaint.There are manufacturing controls to avoid potential causes related to confirmed malfunction the reported malfunction.

• 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 ; 9492503939
• MDR Report Key: 22468644
• Report Number: 2015691-2025-05594
• Device Sequence Number: 4149308
• Product Code: KRA
• UDI-Device Identifier: 07460691954748
• UDI-Public: (01)07460691954748(17)270204(11)250204(10)66283795
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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
• Device Model Number: PXVK0670
• Device Lot Number: 66283795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2025
• 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