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

Model Number	PX284
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	High Blood Pressure/ Hypertension (1908)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product an investigation will be completed to consider any potential factors that may have contributed to this complaint and 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 an intensive care patient with disseminated intravascular coagulation (dic), this disposable pressure transducer (dpt) connected to the radial catheter, displayed an abnormally low blood pressure value.Consequently, the patient was treated with a high dose of vasopressors as fluid resuscitation.Since the values did not change after administering medication, another pressure sensor was connected to the femoral vein, which showed pressure values 10mmhg higher, considered correct as per patient condition.Also a cuff was connected and showed pressure values which were in between the radial and the femoral values and were also considered to be correct.There was no error message displayed.There was no allegation of patient injury.
Additional Manufacturer Narrative
Updated section d9 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.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.There are manufacturing controls to related to the reported 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 ; 9492017706
• MDR Report Key: 24544725
• Report Number: 2015691-2026-12650
• Device Sequence Number: 20227105
• Product Code: DXO
• UDI-Device Identifier: 07460691950214
• UDI-Public: (01)07460691950214(17)270728(11)250728(10)66844017
• 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): N
• Reporter Type: Manufacturer
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PX284
• Device Lot Number: 66844017
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2025
• 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
• Patient Age: 76 YR
• Patient Sex: Male