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

Model Number	PXVMP184
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during blood sampling with this pressure monitoring set, the vamp tubing detached.The tubing could not be reassembled as it was completely detached.It was noted that this issue has occurred previously.There is no allegation of patient injury.The device was available for evaluation.Patient demographics were not provided.
Additional Manufacturer Narrative
As reported, during blood sampling with this pressure monitoring set, the vamp tubing detached.The tubing could not be reassembled as it was completely detached.It was noted that this issue has occurred previously.There is no allegation of patient injury.The device was available for evaluation.Patient demographics were not provided.
Additional Manufacturer Narrative
Upon further review, h6 (investigation findings) and h6 (investigations conclusions) were updated to better reflect the investigational results.It could be determined that the issue is related to the bonding process during the device manufacturing.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation) updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).Finally, the device was not available for evaluation despite due diligent attempts.Without return of the product, a complete investigation of the reported event is unable to be performed.Nevertheless, images were provided for review.Based on the image evaluation, the report of "vamp tubing detached" was confirmed.First image showed a tyvek pouch from reported model and lot number and other two images showed what appeared to be pressure tubing detached from vamp reservoir bond joint.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 implemented 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 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; san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; state rd indus pk 402 km 1.4; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 23923169
• Report Number: 2015691-2025-10623
• Device Sequence Number: 9012759
• Product Code: DXO
• UDI-Device Identifier: 07460691955103
• UDI-Public: (01)07460691955103(17)270530(11)250530(10)66691943
• 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,Followup
• Report Date (Section B): 02/10/2026

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
• Operator of Device: Health Professional
• Device Model Number: PXVMP184
• Device Lot Number: 66691943
• Was Device Available for Evaluation?: Yes
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 02/06/2026; 02/09/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/09/2026; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2025
• 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