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

Model Number EVHRS

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2016

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon return of the product a supplemental report will be submitted with the investigation results.The device service history record review was completed and documented that the device met all specifications upon distribution.

Event Description

It was reported that while monitoring a patient during a neck surgery there was a blood pressure reading discrepancy.There was a difference of 20 ¿ 30mmhg between the clearsight system and the nibp (non-invasive blood pressure).The patient also had an arterial line with a flotrac which correlated with the nibp.When the discrepancy was observed with the clearsight system, the clinician discontinued use of the system.There was no patient harm or injury.

Manufacturer Narrative

One ev1000ni heart reference sensor was received for product evaluation.The examination found that when the product was tested, per the final acceptance tester (fat), that the product passed the test on three separate occasions without any error messages noted.All results were normal.The ft2 calibration test was completed and the product failed the test.An x-ray was performed and it was found that there were open traces on the internal flat flex cable.The flat flex cable connects the dpt sensor to the printed circuit board inside the hrs unit.The damage is consistent with the product being twisted or strained during use.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The reported complaint was confirmed by evaluation.Although the root cause of the damage cannot be conclusively determined, handling factors may have contributed to the issue.The operators manual pn 157811 appendix e states the proper handling of the product by the end user.Corrective and preventive action has been generated to address this issue.

• Brand Name: CLEARSIGHT EVHRS
• Type of Device: NON-INVASIVE HEART REFERENCE SENSOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: lynn selawski ; one edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5778621
• MDR Text Key: 49054659
• Report Number: 2015691-2016-02167
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2017
• Device Model Number: EVHRS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2015
• 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