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

Model Number	PXMK2041
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported; after observing a damped waveform during use in patient of this disposable pressure transducer (medwatch (b)(4)), it was detected a problem in the saline flow rate.It led to the saline bag of 500 ml getting empty and the solution entering the patient in less than 24 hours.Another transducer (medwatch (b)(4)) and saline bag were changed but the same issue occurred, leading to other 500 ml of saline entering the patient.A total of 1000 ml of saline entered the patient in 48 hours.Blood was checked, the device was replaced with a new unit and the issue was solved.There was no allegation of patient injury.As a summary, two medwatch reports were submitted (b)(4).
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 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.
Additional Manufacturer Narrative
Updated section b5, h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).Added related report ref in h10.It was further informed that the device was not available for evaluation since it was discarded at hospital.Without return of the product, edwards is unable to perform a complete investigation of the reported event.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.Corrected data: corrected h6 (device code).
Event or Problem Description
As reported; after observing a damped waveform during use in patient of this disposable pressure transducer (report ref 2015691-2025-00807), it was detected a problem in the saline flow rate.It led to the saline bag of 500 ml getting empty and the solution entering the patient in less than 24 hours.Another transducer (report ref 2015691-2025-00808) and saline bag were changed but the same issue occurred, leading to other 500 ml of saline entering the patient.A total of 1000 ml of saline entered the patient in 48 hours.There was a level increase to 150 meq/l na+ in the arterial blood gas.The device was replaced with a new unit and the issue was solved.No further information is available at this time.There was no allegation of patient injury.

• 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: 21321840
• Report Number: 2015691-2025-00807
• Device Sequence Number: 8129126
• Product Code: DXO
• UDI-Device Identifier: 57460691951469
• UDI-Public: (01)57460691951469(17)260401(11)240401(10)65597954
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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 Expiration Date: 04/01/2026
• Device Model Number: PXMK2041
• Device Lot Number: 65597954
• Was Device Available for Evaluation?: No
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• 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: 61 YR
• Patient Sex: Male