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

Model Number EVHRS

Device Problem Incorrect Measurement (1383)

Patient Problem No Patient Involvement (2645)

Event Date 07/05/2017

Event Type  malfunction  

Manufacturer Narrative

The device was returned for examination and the evaluation is in progress.Upon return of the evaluation results a supplemental report will be submitted with the evaluation findings.

Event Description

It was reported that the heart reference sensor (hrs) would either fail to zero or once zeroed would not change pressure readings when the hrs was repositioned.This occurred prior to patient use.An edwards representative was performing a routine check of the hospital equipment.Once the device zeroed successfully, the zero offset number did not change when the two ends of the hrs unit were repositioned.The device should detect pressure differences at different heights.There were no error messages observed.The suspect hrs device was exchanged for another hrs unit and there was resolution to the issue.There is no other suspect equipment involved.There was no patient involvement.

Manufacturer Narrative

One heart reference sensor (hrs) was received for product evaluation.The suspect hrs unit was connected to a known good working clearsight system for analysis and testing.The sensor did not respond appropriately to differences in bladder and sensor height changes.The suspect hrs was flexed near the hdmi connector, thus flexing the internal flat flex cable, and the zero offset values fluctuated.The sensor was able to be zeroed and there were normal blood pressure readings that were obtained.A visual inspection was performed and there was no physical damage and no oil leakage found.An x-ray was taken and there were damaged trace wires that were found on the flat flex cable.The hrs unit failed to function properly prior to being successfully zeroed.The operator¿s manual states that ¿the ev1000 clinical platform ni is intended for use only as an adjunct in patient assessment.This instrument should be used in conjunction with a bedside physiologic monitor.¿ if pressure measurements are inaccurate, the clinician will detect the difference and perform troubleshooting procedures.The root cause of the damaged flat flex cable is repetitive movement or flexing during use.The repetitive movement leads to fractures.A more durable discrete wire design was made and sold as of february 2017.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The reported issue was confirmed by evaluation.The issue has been escalated and corrective action implemented.This issue will continue to be monitored.

• 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: 6746829
• MDR Text Key: 81152285
• Report Number: 2015691-2017-02238
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/05/2017

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: 11/01/2018
• Device Model Number: EVHRS
• Device Catalogue Number: EVHRS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2017
• Initial Date FDA Received: 07/27/2017
• Supplement Dates Manufacturer Received: 07/28/2017
• Supplement Dates FDA Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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