MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT EVHRS; NON-INVASIVE HEART REFERENCE SENSOR

Model Number EVHRS

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Malposition of Device (2616)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

The device has not been received for examination.When the evaluation findings are available a supplemental report will be submitted.The device service history record review has not been completed.When the results are available a supplemental report will be submitted.(b)(4).

Event Description

It was reported that during patient monitoring with clearsight technology that the heart reference sensor (hrs) device provided inaccurate blood pressure readings.This was because the hrs device fell from the patient off of the or table.The anesthesiologist noticed at the 30 minute intermittent nibp cycle that the hrs device was incorrectly positioned.The appropriate position of the hrs was to be at the patient¿s heart level.The blood pressure reading was 30mmg higher than expected at 130/90 for about 30 minutes.The hrs device was then correctly positioned.The patient¿s actual blood pressure was 100/70.Non-invasive blood pressure monitoring was being used with clearsight monitoring during surgery.The patient was undergoing a kidney transplant surgery.The patient treatment was altered as more fluid would have been given even though svv was low.They did not use vasopressors on the patient.There was no harm or injury to the patient.This event was not a result of a product malfunction.

Manufacturer Narrative

One heart reference sensor (hrs) was returned for product evaluation.The suspect hrs device was connected to a known good working clearsight system and patient simulator for analysis and testing.The pressure readings were appropriate and were not running ¿out of range.¿ there was no defect found.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure readings should correlate with the patient¿s clinical manifestations.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make such decisions.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.There was no patient injury or compromise in this event.The patient demographic information was not provided.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 the monthly review.The product evaluation did not confirm any defect with the hrs device.The root cause of the issue is consistent with user error.There is no evidence or indication that a manufacturing defect is a contributing factor; therefore, no corrective action was taken.The facility was provided education and training by an edwards clinical field specialist/nurse practitioner as to the proper use of the hrs device.The issue will continue to be monitored and trended as part of the management review process.No further action will be taken at this time.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: CLEARSIGHT EVHRS
• Type of Device: NON-INVASIVE HEART REFERENCE SENSOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92714
• MDR Report Key: 7928259
• MDR Text Key: 122451661
• Report Number: 2015691-2018-04001
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• PMA/PMN Number: K140312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/23/2018
• Device Model Number: EVHRS
• Device Catalogue Number: EVHRS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1