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

Model Number	PXAVMP
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/03/2024
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.The dhr could not be completed as no serial number was 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
It was reported during use that the pxavmp vamp and tubing separated causing backflow of blood out of the patient when the primary nurse was leveling the transducer of the arterial line.With timely intervention the line was preserved and patient blood loss was minimal.There was no substantial pressure applied to the connection in the process of leveling the transducer and minimal manipulation of the line during movement.Another identical device was obtained and used on the patient and no harm occurred from this event.Subject was a 41 year old male.
Additional Manufacturer Narrative
The pxavmp pressure monitoring kit was returned for evaluation.Customer report of tubing separated was confirmed.As received pressure tubing was completely detached from bond joint with vamp adult reservoir.Indication of bonding material was evident on tubing bond surface area.Tubing od 0.1405 inches measured near the point of detachment was within specification.No other visible damaged was observed from the returned kit.Since the lot number was not reported the device history review could not be performed.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing design defect.Therefore a root cause could not be established.As part of the manufacturing process manufacturing controls to avoid potential causes related to both conditions reported of bond tubing to reservoir detached include 100% visual inspection manufacturing continuous monitoring sampling and qa sampling inspection.

• 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: erika bonilla ; one edwards way; irvine, CA 92614
• MDR Report Key: 20614904
• Report Number: 2015691-2024-08351
• Device Sequence Number: 7553112
• Product Code: KRA
• UDI-Device Identifier: 00690103011494
• UDI-Public: 00690103011494
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 01/21/2025

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: PXAVMP
• 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: 10/25/2024
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 01/21/2025
• 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 Age: 41 YR
• Patient Sex: Male