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

Model Number MHD6R

Device Problem Incorrect Measurement (1383)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/21/2022

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 a supplemental report will be sent with the investigation results.

Event Description

As reported, during use in patient under septic shock with this flotrac sensor, the mean arterial pressure (map) increased uncontrollably; therefore the patient was incorrectly weaned off norepinephrine and antihypertensive drugs were administered.Since the map was not controlled, the doctor checked the blood pressure using a cuff, which provided a value of 32 mmhg.Based on that, they decided to change the access from femoral to radial.After that, the difference between the cuff and the flotrac sensor was around 70 points.The curve displayed on the hemosphere monitor was not pinched.Reportedly, there was no injury to the patient.Follow-up has started for device return.

Manufacturer Narrative

One flotrac sensor was received at our product evaluation laboratory for a full evaluation.The report of inaccurate values could not 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.During flotrac output drift testing, pressure did not show any drift during output drift testing, and met specification.Dpt pressure did not show any drift during output drift testing and met specification.Electrical testing showed that both input and output impedance were within specifications.Zero-offset also met specification.No leakage or occlusion was detected from the kit during pressure test.No visible damage was observed from the kit.The lot/serial number for this device was not supplied.Therefore, the related manufacturing records for this device were unable to 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.

• 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: 16182917
• MDR Text Key: 307488373
• Report Number: 2015691-2023-10235
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MHD6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 60 KG