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

Model Number	PXAVMP3
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation 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, when the respiratory therapist touched the right radial arterial line tubing the tubing pulled out/became disconnected from the vamp and blood drained on the floor.The rn was able to clamp the line and attach new vamp and tubing to a line hub.There was no allegation of patient injury.
Additional Manufacturer Narrative
One model pxavmp3 dpt, without any attached component, was returned for product evaluation.The customer report of tubing pulled out/disconnected from the vamp was not able to be confirmed.The vamp system and tubing set were not returned with the dpt unit.No visible damage was observed from the returned dpt.The dpt was primed without any problem.The dpt zeroed and sensed pressure on hemosphere monitor.No leakage was noticed from the dpt during pressure test.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Since the complaint affected unit was returned for evaluation and no defect was found a product non-conformance or device failure associated to manufacturing or design could not be confirmed.As part of the manufacturing process, 100% of the units go through continuous monitoring sampling, qa sampling inspection, and a visual inspection.The device history record review was performed and no manufacturing non conformances were identified associated to the reported malfunction.

• 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 IRVINE; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 22391816
• Report Number: 2015691-2025-05410
• Device Sequence Number: 18423610
• Product Code: KRA
• UDI-Device Identifier: 07460691950085
• UDI-Public: (01)07460691950085(17)261120(11)241120(10)66118580
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 09/15/2025

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: PXAVMP3
• Device Lot Number: 66118580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• 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