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

Model Number MHD8

Device Problem Incorrect Measurement (1383)

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

Event Date 12/13/2021

Event Type  malfunction  

Manufacturer Narrative

Follow up is on going to clarify whether the device is available for evaluation.An investigation will be performed in order to consider any potential factors that may have contributed to this complaint.The serial number was not provided.Therefore, the device history record (dhr) could not be reviewed.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.Investigation is ongoing to know whether the product is available for evaluation.

Event Description

The following information was obtained through an article published on frontiers in pediatrics 2021: anesthetic management and electrical cardiometry as intensive hemodynamic monitoring during cheiloplasty in an infant with enzyme-replaced pompe disease and preserved preoperative cardiac function.During use in a 4 months old infant with a flotrac sensor for hemodynamic monitoring during cheiloplasty, the health care professionals focused on three parameters of flotrac: cardiac output (co), stroke volume variation (svv) and systemic vascular resistance (svr) provided by the flotrac deviated from physiological range and the values were too inaccurate to reflect the clinical condition.The co, svv, and svr was compared between two hemodynamic monitors.Patient was not treated based on the flotrac values.

Manufacturer Narrative

Added information to section d4 (model number) and (e1 address - line 1, post office or zip code).It was further informed that the device was not available for evaluation since it was discarded at hospital.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.

Manufacturer Narrative

Based on further engineering investigation, there are manufacturing controls to avoid potential causes related to the reported malfunction.Additionally, the electronic instructions for use for the product was reviewed, as result it was confirmed that there are clear instructions of the device usage and warnings related to the misuse of the flotrac sensor.

• Brand Name: FLO TRAC SENSOR
• Type of Device: 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: 16611300
• MDR Text Key: 312298027
• Report Number: 2015691-2023-11818
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MHD8
• Device Catalogue Number: MHD8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 4 MO
• Patient Sex: Female
• Patient Weight: 6 KG