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 Resultor Readings (1535); Device Slipped (1584)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2018

Event Type  Injury  

Manufacturer Narrative

The device has been received for examination and the evaluation is in progress. 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 off of the patient¿s gown and dropped to the floor. It had been secured by a clip to the gown, but came loose and fell off. The appropriate position of the hrs was to be at the patient¿s heart level. The patient was on anti-hypertensive treatment. At some point during titration of medication is when the hrs device fell off. This led to a period of time where the sbp, dbp and map was about 40mmg higher than the actual blood pressure reading. When the edwards clinical field specialist returned to the er she realized that the hrs was positioned incorrectly. At the time the blood pressure reading was 160/100. When the hrs was placed at heart level the blood pressure reading was 110/70. Non-invasive blood pressure monitoring was being used with the clearsight monitoring during surgery. This was a hypertensive crisis patient with blood pressure of 240/140s in the er. 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 for analysis and testing. The hrs device was able to be zeroed appropriately and there were no error messages noted. A normal waveform and normal blood pressure readings were able to be obtained without any issues. The device passed the ft2 functional testing. A visual external inspection was performed and there was no physical damage identified. There was no defect found. 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.

• Brand Name: CLEARSIGHT EVHRS
• Type of Device: NON-INVASIVE HEART REFERENCE SENSOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 7928257
• MDR Text Key: 122453023
• Report Number: 2015691-2018-04000
• 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

0 Patients were 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

• Device Expiration Date: 09/06/2018
• Device Model Number: EVHRS
• Device Catalogue Number: EVHRS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No