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

Model Number	VP2
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	07/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during set up of this pressure monitoring set with vamp, the arm mount sample site tubing was detached from the connector.There was no allegation of patient injury.Patient demographic information unable to be obtained.
Additional Manufacturer Narrative
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.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
Updated section h6 (component code), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusion).The device involved in this case was received by our product evaluation laboratory for a full evaluation.The report of "arm mount sample site tubing was detached from the connector" was unable to be confirmed.As received, all connections were tight and secure.No visible damage was observed from returned kit during visual inspection.No leakage was detected from the kit during leak test.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met and inspections passed successfully.Further engineering evaluation, no root cause could be determined since the reported malfunction could not be confirmed.However, there are manufacturing controls such as visual inspection, sampling inspection, manufacturing continuous monitoring sampling and leak test to avoid potential causes related to the reported pressure tubing detached malfunction.

• Brand Name: VAMP PLUS 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: 20117195
• Report Number: 2015691-2024-06793
• Device Sequence Number: 20657216
• Product Code: KRA
• UDI-Device Identifier: 07460691944831
• UDI-Public: (01)07460691944831(17)260413(11)240413(10)65652600
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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: 04/13/2026
• Device Model Number: VP2
• Device Lot Number: 65652600
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 09/02/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2024
• 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