MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR FLOTRAC SENSOR; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number	MHD8
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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.
Event or Problem Description
As reported, after being correctly connected, this flotrac sensor consistently displayed a significantly low diastolic blood pressure of 10 mmhg, despite the expected normal range being 60/80 mmhg.No error message was displayed.The patient was not treated according to the incorrect values.The issue was solved replacing the unit.There was no allegation of patient injury.The device was available for evaluation.Patient demographics unable to be obtained.
Additional Manufacturer Narrative
Added information to section d5 (operator of device) and d9 (device availability).Updated information to section h6 (type of investigation, investigation findings, investigation conclusions).The device was received for evaluation.Customer report of incorrect values was unable to be confirmed.Both flotrac and dpt (disposable pressure transducer) sensors zeroed and sensed pressure accurately on a ev1000 monitor and pressure monitor respectively.No error message was observed on a ev1000 monitor.The pressure did not show any drift during output drift testing and met specification.Electrical testing showed that both input impedances and output impedances for flotrac and dpt sensors were within specifications.Zero-offset for flotrac and dpt sensors also met specification.No leakage or occlusion was detected from the kit during pressure test.No visible damage was observed from the kit.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.In addition, there are manufacturing controls to avoid potential causes related to the reported malfunction, such as electrical testing.No further investigation could be performed, since no defect was confirmed during the product evaluation.

• Brand Name: FLOTRAC SENSOR
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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: 22802671
• Report Number: 2015691-2025-06632
• Device Sequence Number: 20747443
• Product Code: DRS
• UDI-Device Identifier: 00690103194609
• UDI-Public: (01)00690103194609(17)260624(11)240624(10)65844212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K242909
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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: 06/24/2026
• Device Model Number: MHD8
• Device Lot Number: 65844212
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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 Sex: Unknown