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

Model Number	PXVK0670
Medical Device Problem Codes	Incorrect Measurement (1383); High Readings (2459)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
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, during use in patient with this disposable pressure transducer, the arterial line was showing a mean arterial pressure (map) of 100 mmhg.No alarms or error messages were displayed.Manual blood pressure was done with a very clear 70/40 mmhg with a map equaling 50.Arterial line re zeroed, checked pressure bag, checked cannula for kinks, ensured transducer was in correct place and got a new cable.Still showing a blood pressure with a map of 100.New transducer line primed and connected, showing an accurate blood pressure with a map of approximately 50 mmhg.Blood pressure was treated accordingly.As per customer opinion, the inaccurate value issue resulted in an extended period of patient hypotension which could cause a patient injury, therefore this was reported as an injury.Patient demographics unable to be obtained.The device was available for evaluation.
Additional Manufacturer Narrative
Updated: d9 (device availability), h3 (device evaluated by manufacturer), h6 (component code, device code, type of investigation, investigation findings, investigation conclusions).The pressure monitoring set was not received for evaluation.Therefore, no evaluation could be performed since no objective evidence was provided for investigation.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met, and inspections passed successfully.Additionally, it could be verified that there are manufacturing controls in place to prevent this type of malfunction in our manufacturing process as leak, voltage, electrical and capacitance test for all units.As such, based on available information, a definite root cause is unable to be determined at this time.
Additional Manufacturer Narrative
Update section d9.Updated section h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).Finally, the device was received for evaluation.The report of inaccurate values was not able to be confirmed.The disposable pressure transducer zeroed and sensed pressure accurately on pressure monitor.Pressure did not show any drift during output drift testing and met specification.Electrical testing showed that both input impedance and output impedance were within specifications.Zero-offset also met specification.No leakage or occlusion was detected from the kit during pressure test.No visible damage was observed from the kit.No further evaluation was performed since no defect was identified during the device evaluation.

• 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: 19258525
• Report Number: 2015691-2024-03391
• Device Sequence Number: 6492684
• Product Code: DXO
• UDI-Device Identifier: 07460691954748
• UDI-Public: (01)07460691954748(17)251204(11)231205(10)65178899
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181684
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2025

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 Expiration Date: 12/04/2025
• Device Model Number: PXVK0670
• Device Lot Number: 65178899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/16/2024
• Supplement Date Received by Manufacturer: 06/13/2024; 03/06/2025
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 06/14/2024; 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• 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