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

Model Number	48VMP160
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, after arterial blood draw for blood gas testing with this vamp system, the sampling site septum slipped into the tubing causing blood leakage.The blood leakage was minimal and no additional intervention was needed.There was no allegation of patient injury.The device was available for evaluation.
Additional Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not been received yet.Upon the return of the product a supplemental report will be sent with the investigation results.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.
Additional Manufacturer Narrative
The device was received for evaluation.The silicone disk was stuck down into sample site housing.The edge at the top of sample site housing appeared not bent down and inwards.No other visible defect or damage was observed from the unit.Based on the evaluation results the failure was found to be related to the silicone disk being stuck down into the sample site housing rather than the sampling site septum dislodged/detached as initially reported.If the septum or rubber from sampling becomes stuck or difficult to move, this may impact the ability to perform blood sampling, or may result in a small amount of blood or fluid loss.If unable to be resolved, the device will have to be exchanged with minor delay in monitoring/treatment.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 ; 9492503939
• MDR Report Key: 20890460
• Report Number: 2015691-2024-09425
• Device Sequence Number: 15714246
• Product Code: DXO
• UDI-Device Identifier: 07460691950610
• UDI-Public: (01)07460691950610(17)260326(11)240326(10)65652855
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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: 03/26/2026
• Device Model Number: 48VMP160
• Device Lot Number: 65652855
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2024
• 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