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

Model Number EVHRS

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2016

Event Type  malfunction  

Manufacturer Narrative

An investigation was done as a result of the inaccurate blood pressure reading that was received at this event.An edwards rn/bsn visited the facility to further investigate.She provided extensive education and training on the proper use of the products to the bio-medical and nursing staff at the hospital.It was determined that the end user had improperly placed the finger cuff on the patient and therefore, could not obtain an accurate bp reading.She demonstrated the proper set-up and use of the edwards ev1000ni clearsight system.The product will not be returned to edwards for evaluation.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.Please refer to three other submissions for other units involved; ev1000 platform, pressure controller, and pump unit.

Event Description

It was reported that while monitoring a patient with the non-invasive clearsight system, the patient¿s blood pressure reading displayed on the ev1000ni monitor above 190 systolic.A manual blood pressure reading was then taken on the upper arm of the patient and the blood pressure reading was around 120 systolic.The physician removed the clearsight system and inserted an arterial line into the patient for monitoring.The patient was not treated with the inaccurate value.There was no patient harm or injury.

Manufacturer Narrative

There are other components that were involved in this event.Here are the submission report numbers: ev1000 platform 2015691-2016-00687 pressure controller 2015691-2016-00688 pump unit 2015691-2016-00690 finger cuff 2015691-2016-00720 in the initial report submitted on march 7, 2016.Indicated that there were three other submissions for the units involved.That should be changed to four other submissions as listed above.

• 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 ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5483763
• MDR Text Key: 40086011
• Report Number: 2015691-2016-00689
• 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: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2017
• Device Model Number: EVHRS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 03/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2015
• 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