MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT SYSTEM; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number EVHRS

Device Problems No Device Output (1435); Appropriate Term/Code Not Available (3191)

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

Event Date 04/26/2022

Event Type  malfunction  

Manufacturer Narrative

Follow-up ongoing regarding the device return.An investigation will be completed to consider any potential factors that may have contributed to this complaint.

Event Description

As reported, with this heart reference sensor (evhrs) a fault error message was displayed and an orange light appeared.As the patient still required advanced monitoring, an arterial line was inserted and flotrac sensor was used instead.There was no allegation of patient injury.Patient demographics were requested, but unable to be obtained at this time.

Manufacturer Narrative

Any failure of the hrs that results in the absence of hemodynamic monitoring will prompt the user to perform troubleshooting.If unable to correct, any of the devices that are a part of the system can be replaced with a minor delay in treatment/monitoring.However, in this case patient still required advanced monitoring and new access to connect the flotrac was needed.If the patient requires a new needle stick for device access, there is greater potential risk of infection and bleeding.The hrs involved in this case was not available for evaluation.Further investigation was performed by the engineers.The manufacturing records were reviewed and there is no indication of a related nonconformance.All process parameters were met, and inspections passed successfully.In addition, device manufacturer date and expiration date fields were updated their respective fields.Adverse event problem codes in h6 were also updated in order to better reflect the nature of the finding.Patient demographics were requested, but not available.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.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

The device involved in this case was further received at edwards technical services for evaluation.Based on evaluation performed, when connected to a known working system, this hrs caused the fault message for hrs or hrs connection error and the hrs led on the pressure controller turned orange.When the sensor housing was taken apart found that there was oil residue inside and oil was covering the sensor board.No active oil leaks from the tubing or sensor frame were found.Then, when opened the housing that hold the connector board and it was verified that there were no liquids on that board.It was found that the blue wire was misrouted, but there was no visible physical damage to the wire.The reported event was confirmed, since per product evaluation, oil leakage was found that likely affected the unit and caused the error message.Based on further investigation was performed by the engineers, the potential failure of the oil leakage when there is not damage to the hrs device is the insufficient sealing ball, that caused the oil leakage and a mitigation step is in place to prevent monitoring.This failure is attributed to design.Upon further review, the adverse event problem codes (h6) were updated in their respective fields in order to better reflect the nature of the finding.

• Brand Name: CLEARSIGHT SYSTEM
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 14642408
• MDR Text Key: 301272591
• Report Number: 2015691-2022-06117
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203131
• 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,Followup
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2023
• Device Model Number: EVHRS
• Device Catalogue Number: EVHRS
• 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: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1