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

Model Number	PXVMP184
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product evaluation was completed on the returned pressure tubing with vamp.The reported event of tubing disconnected at the vamp was confirmed.As received, 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 outer diameter was 0.1425" near the point of detachment, which was within specification.No other visible damage or inconsistency was found from returned kit.The engineering evaluation is anticipated.A supplemental report will be forthcoming when the investigation is completed.The lot number was not provided thus a device history record cannot be reviewed.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.Additional fda product code kra.Additional fda premarket submission are k173586 and k896819.
Event or Problem Description
It was reported that the iv tubing of a vamp pressure tubing broke and disconnected at the vamp.This occurred upon drawing back on vamp during blood sampling.There were no patient injuries reported.
Additional Manufacturer Narrative
An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.This condition has been investigated by the applicable cross functional team and as part of the complaint investigation process, no specific root cause was identified.Per the manufacturing process, 100% of the units undergo a visual inspection, manufacturing continuous monitoring sampling, and quality assurance sampling inspection.

• Brand Name: TRUWAVE, VAMP
• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 21660114
• Report Number: 2015691-2025-02123
• Device Sequence Number: 18199167
• Product Code: DXO
• UDI-Device Identifier: 07460691955103
• UDI-Public: 07460691955103
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

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
• Device Model Number: PXVMP184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 05/07/2025
• 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