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
Additional Manufacturer Narrative
Corrected data: section h10 related report number.Manufacturer narrative: updated section b5 (there was a level increase to 150 meq/l na+ in the arterial blood gas).
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.
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.
Event or Problem Description
As reported, after observing a damped waveform during use in patient of this disposable pressure transducer (medwatch 60869), 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 61038) 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 (ref.60869 and 61038).
Additional Manufacturer Narrative
Corrected section h6 (device code) updated section d9 (device available for evaluation), h3 (device evaluated by manufacturer), h6 (component code, type of investigation, investigation findings, investigation conclusions) the pressure monitoring set involved in this event was received for evaluation.Customer report of "incorrect flow rate" was confirmed.The returned pressure monitoring kit was primed and flushed without any indication of occlusion or flow restriction.The dpt sensor zeroed and sensed pressure accurately on pressure monitor.Flow rate through the dpt was measured and it was out of specification.No visible damage was observed from the kit.As per further evaluation, a leak test was performed with red dye solution injected from iv side of the dpt housing.Red dye solution passed through the flush device at close position.The poppet was found not completely seal the fluid path at close position.No visible damage or defect was observed from poppet or flush device housing.Based on further investigation at the manufacturing site, there are manufacturing controls to avoid potential causes related to the reported malfunction, but according to the available information, there is not enough objective evidence to conclude the reported malfunction is manufacturing related and a root cause could not be established.Nevertheless, the manufacturing personnel has been notified about this condition.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.

• 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: 21321847
• Report Number: 2015691-2025-00808
• Device Sequence Number: 20865321
• 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,Followup
• Report Date (Section B): 04/25/2025

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?: 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: 01/14/2025
• Supplement Date Received by Manufacturer: 03/11/2025; 04/24/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/20/2025; 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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