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

Model Number FLOTRAC UNKNOWN

Device Problem Incorrect Measurement (1383)

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

Event Date 04/01/2018

Event Type  malfunction  

Event Description

As per review of literature article accuracy, precision, and trending of 4 pulse wave analysis techniques in the postoperative period (m.Geisen, m.T.Ganter, s.Hartnack, et al.), the following complaint was identified: in patients admitted to the intensive care unit after cardiac surgery flotrac (medwatch 27565) and nexfin (medwatch 27566) do not reliably display changes in cardiac output after fluid administration in the study group of patients.Per the study, the devices were used as additional monitoring systems, as the reference values were obtained from transpulmonary thermodilution.This information reasonably suggests the patients did not receive any treatment due to the inaccurate values.Additionally, the study states that no adverse events regarding the use of the study devices were recorded.Patient demographics were requested and unable to be obtained.

Manufacturer Narrative

No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.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.

Manufacturer Narrative

Based on further engineering investigation, the instructions for use 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.Additionally, there are manufacturing controls to avoid potential causes related to the reported malfunction malfunction.

• 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: 16591446
• MDR Text Key: 312314070
• Report Number: 2015691-2023-11762
• 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
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLOTRAC UNKNOWN
• Device Lot Number: UNKNONWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: No
• 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