MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, DR FLOTRAC SENSOR; CATHETER, FLOW DIRECTED

Model Number	MHD8
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during use in patient, this flotrac sensor provided an inaccurate output.The issue was solved replacing the device.No further information available regarding the inaccurate values obtained.There was no allegation of patient injury, and patient was not treated according to the inaccurate values.
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
The device was received for evaluation.The report of "inaccurate output" could not be confirmed.Both flotrac and dpt sensors of the flotrac unit zeroed and sensed pressure accurately on ev1000 and pressure monitor.No error message was noticed on the monitors.Pressure did not show any drift during output drift testing and met specification.The electrical testing showed that both input impedance and output impedance 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 sensor during leak test.No visible damage was observed from the sensor.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.No further investigation was performed since no defect was confirmed during product evaluation patient demographic data not provided due to local law in south korea prevent any disclose of personal information.

• Brand Name: FLOTRAC SENSOR
• Common Device Name: CATHETER, FLOW DIRECTED
• 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: 20133797
• Report Number: 2015691-2024-06834
• Device Sequence Number: 17961325
• Product Code: DYG
• UDI-Device Identifier: 00690103194609
• UDI-Public: (01)00690103194609(17)250625(11)230626(10)65170728
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K231248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: 06/25/2025
• Device Model Number: MHD8
• Device Lot Number: 65170728
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2023
• 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