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

Model Number MHD6

Device Problem Incorrect Measurement (1383)

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

Event Date 05/23/2023

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product an investigation will be completed to consider any potential factors that may have contributed to this complaint and 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 Description

As reported, in a patient under extracorporeal circulation for a coronary artery bypass graft and valve replacement surgery, this flotrac sensor leaked and provided arterial blood pressure value 10mmhg lower than the one measured with the non-invasive blood pressure system.The issue was found out after the patient became hypotensive and was treated with norepinephrine 1mg drop pot sedation.Patient's vital signs were closely observed for changes, and surgical treatment continued to be completed.Patient did not became hypertensive due to incorrect treatment received.There was no error message displayed.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

Added information to section d4 (expiration date) and h4 (device manufacturer date) updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusion).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.

Manufacturer Narrative

One flotrac unit was received by our product evaluation laboratory for a full examination.The report of leakage and pressure issue was unable to be confirmed.Both flotrac and dpt sensors of 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.Electrical testing showed that both input impedance and output impedance for flotrac and dpt sensors were within specifications.Zero-offset for both sensors also met specification.No leakage or occlusion was detected from the sensor during leak test.No visible damage was observed from the 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 Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 17277050
• MDR Text Key: 318566774
• Report Number: 2015691-2023-14405
• 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,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MHD6
• Device Catalogue Number: MHD6
• Device Lot Number: 64453326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2022
• 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: 63 YR
• Patient Sex: Male