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

Model Number	PX200
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Codes	Weight Changes (2607); Hypervolemia (2664); Unspecified Respiratory Problem (4464)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4.Weight 740 grams.The product is expected to be returned for analysis; however, it has not been received yet.Upon the return of the product, a supplemental report will be sent with the investigation results.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 part of this monthly review.
Event or Problem Description
As reported, during use in a neonatal patient, this pressure monitoring kit administrated too much fluid because of higher flow rate: from 0.2 to 0.3 cc/hour.The volume of saline administrated over 48 hours was about 120ml.All the connections were correctly made.Then, it was decided to remove the umbilical catheter.The patient had an electrolyte imbalance, gained too much weight, and suffered a respiratory degradation.Unknown medication was provided for ionic rebalancing.The device was available for evaluation.
Additional Manufacturer Narrative
Updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).Finally, the device was not available for evaluation despite due diligent attempts.Without return of the product, a complete investigation of the reported event is unable to be performed.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.All process parameters were met and inspections passed successfully.There are manufacturing controls to related to the "during use incorrect flow rate" malfunction.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• 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 LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 24494587
• Report Number: 2015691-2026-11682
• Device Sequence Number: 4979706
• Product Code: DXO
• UDI-Device Identifier: 07460691950528
• UDI-Public: (01)07460691950528(17)270428(11)250428(10)66598122
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PX200
• Device Lot Number: 66598122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 DA
• Patient Sex: Male