MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EV1000 CLINICAL PLATFORM WITH CLEARSIGHT FINGER CUFF OR CLEARSIGHT SYSTEM; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number EV1000NI

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned and evaluated.However, at the time of this report, it had not yet been received.A supplemental report will be sent upon receipt and examination of the suspect device.The results of the device history record review will also be communicated in our supplemental follow-up report.

Event Description

During a sales representative demonstration, the clearsight non-invasive platform displayed suspect blood pressure values.The device was tested on four separate patients using different cuffs; however, the issue persisted.There was a difference of approximately 25mmhg in the arterial blood pressure between the clearsight and the arm cuff and between the clearsight and the arterial line (arterial line and arm cuff were similar).No error message was displayed.No patient was treated based on the suspect values and there was no report of patient compromise resulting from this event.

Manufacturer Narrative

Review of the manufacturing records support that there were no non-conformances noted during the manufacturing of the ev1000 ni platform and all specifications were met prior to release.A review of the service history supports that there have been no issues requiring servicing prior to this report.Examination of the returned platform was unable to confirm the reported events.Functional testing per procedure was executed with a golden (known ¿good¿) heart reference sensor (hrs) and the device passed all analysis with no issues noted for any reason.It was noted that the hrs that was sent with the system had already expired (2017-03-01).It is unknown whether the expired hrs, procedural processes or a specific circumstance played a role in the events, as the fault could not be replicated and no other issues were detected; the device performed as expected.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.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.Pressure readings should correlate with the patient¿s clinical manifestations.Issues such as poor finger perfusion, improperly applied finger cuff, incorrectly sized finger cuff, improper application of the hrs or failing to zero the hrs sensor may lead to inaccurate hemodynamic measurements.The operators manual instructs the use on these above stated factors that can lead to inaccurate values.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 a part of the monthly review.

• Brand Name: EV1000 CLINICAL PLATFORM WITH CLEARSIGHT FINGER CUFF OR CLEARSIGHT SYSTEM
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 7106378
• MDR Text Key: 94816202
• Report Number: 2015691-2017-04219
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K160552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Model Number: EV1000NI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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