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

Model Number MHD6AZR5

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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.The date of the event is unknown.Patient demographics unable to be obtained.

Event Description

As reported, during use in a research study, this flotrac sensor displayed mean arterial pressure (map) value in the range of 65-75 mmhg with a difference of 10 mmhg between the philips bedside monitor and the hemosphere monitor.No error message was displayed.Other pressure cables were tried without success.The flotrac sensor was changed and the issue was solved.The patient was not incorrectly treated due to this issue.The surgery was delayed 30 minutes, without consequence to the patient.The device was available for evaluation.Patient demographics unable to be obtained.

• Brand Name: FLOTRAC SENSOR
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 18872877
• MDR Text Key: 337430842
• Report Number: 2015691-2024-01922
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K231248
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MHD6AZR5
• Device Lot Number: 65425333
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1