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

Model Number	PXVMP172
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes include.Dxo transducer, pressure, catheter tip.The device evaluation is anticipated.A supplemental report will be forthcoming when the investigation is completed.The device history record review was not completed as a lot number was not provided.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 use the pressure monitoring set had blood that backed up into the vamp and the rn attempted to apply pressure to the vamp plunger to return the blood.Upon doing so, the tubing proximal to the vamp on the patients side disconnected at the connection point.No air was introduced and there was minimal blood loss as the nurse was present at the time of disconnection.The vamp tubing was changed immediately.There was no patient injury.It is unknown if the device is available for evaluation.
Additional Manufacturer Narrative
A correction is being submitted due to product evaluation findings.One pressure monitoring set was returned for evaluation.Report of tubing to the vamp disconnected was confirmed.As received pressure tubing was found completely broken from the bond joint vamp adult reservoir.Cross surfaces of broken tubing appeared rough and uneven.Therefore, this is no longer considered to be a reportable event.No other visible damage was observed from returned kit.The device history record review was not completed as the lot number was not provided.

• 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: 24334256
• Report Number: 2015691-2026-11089
• Device Sequence Number: 21270941
• Product Code: KRA
• UDI-Device Identifier: 07460691955097
• UDI-Public: 07460691955097
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: PXVMP172
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/02/2026
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 02/24/2026
• 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