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

Model Number	T001691M
Medical Device Problem Codes	Backflow (1064); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device code 1064 backflow has been added.
Additional Manufacturer Narrative
It was further informed that the device was not available for evaluation since it was discarded at hospital.However, imagery was provided for evaluation.Based on the imagery review, two videos were reviewed.- videos showed a vamp plus.Leakage was visible from the bond joint between pressure tubing and reservoir stopcock.An engineering evaluation will be completed to consider any potential factors that may have contributed to this complaint and 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.
Event or Problem Description
As reported, during use in patient with this disposable pressure transducer with vamp systems, there was a saline leakage at the level of the shut-off valve.In addition, there was a blood backflow due to loss of airtightness of the system that must be close.Therefore the system must be changed because it presented filtration and entered air into the system with risk of coagulation and dysfunction.There was no allegation of patient injury.The device was not available for evaluation.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation).Updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product.However, two videos were provided for review.Based on the evaluation of the videos, the report of leakage was confirmed.Videos showed a vamp plus.Leakage was visible from the bond joint between pressure tubing and reservoir stopcock.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.The root cause of the reported condition could be related to the bonding process during the device manufacturing.The manufacturing personnel was notified about this condition.Nevertheless, there are controls to avoid potential causes related to the reported malfunction during the manufacturing process.

• 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: 19339341
• Report Number: 2015691-2024-03684
• Device Sequence Number: 7340086
• Product Code: KRA
• UDI-Device Identifier: 07460691959477
• UDI-Public: (01)07460691959477(17)250731(11)230801(10)65205337
• 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: Other,Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2024

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: 07/31/2025
• Device Model Number: T001691M
• Device Lot Number: 65205337
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: 05/17/2024; 07/29/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 05/17/2024; 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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 Age: 66 YR
• Patient Sex: Male