MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR TRUWAVE, VAMP; CATHETER, CONTINUOUS FLUSH

Model Number	PXVFP11241
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.A supplemental report will be forthcoming when the investigation is completed.The device history record review was not yet 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
As reported during blood sampling during use on a patient the connection between the patient side three way stopcock and the planecta got loosened and detached, then a small amount of blood leakage occurred.When the device was replaced, the problem was solved.The patient was an adult.No transfusion nor extension of hospitalization was required.There was no allegation of patient injury.The device will be available for product evaluation.

• Brand Name: TRUWAVE, VAMP
• 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 ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 24590294
• Report Number: 2015691-2026-13171
• Device Sequence Number: 18508311
• Product Code: KRA
• UDI-Device Identifier: 07460691955097
• UDI-Public: 07460691955097
• Combination Product (Y/N): N
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: PXVFP11241
• Device Lot Number: CP0500MT
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 05/22/2026
• 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