MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR TRUWAVE, VAMP PLUS; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number	PXVP23X3
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	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional fda product codes include: kra- catheter, continuous flush.One vamp adult system was returned for evaluation.The customer eport of defective product was confirmed.As received, the pressure tubing was found completely detached from vamp reservoir bond joint.Indications of what appeared to be bonding material were evident on tubing bond surface area.Tubing od was measured to be 0.1415 inches near the point of detachment, was within specification.Dry blood was visible inside inside the tubing.No other visible damage or inconsistency was found to the returned vamp system.A supplemental report will be forthcoming when the engineering evaluation is completed.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 a part of the monthly review.
Event or Problem Description
It was reported that during use of the pressure monitoring set the blood draws appeared to be diluted.There was no patient injury.

• Brand Name: TRUWAVE, VAMP PLUS
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): BD APM; 17200 laguna canyon rd; irvine CA 92603
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 23352275
• Report Number: 2015691-2025-08705
• Device Sequence Number: 9066297
• Product Code: DXO
• UDI-Device Identifier: 07460691950092
• UDI-Public: 07460691950092
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K142749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

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 Model Number: PXVP23X3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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