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

Model Number EVHRS

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

The product has been received for product evaluation.The evaluation has not been completed.Once the findings are available, a supplemental report will be submitted.The device history record review was completed and all manufacturing inspections passed with no non-conformances.The udi information is (b)(4).

Event Description

It was reported that while zeroing the heart reference sensor (hrs), the offset value was at 30mmhg when it was held near level position.The device was then zeroed properly and was left to run for hours during a case.The edwards clinical field specialist was present and said that the clearsight numbers were 30 points higher than the brachial cuff numbers when he observed.The brachial cuff was reading good values for map>65mmhg.The edwards rep recalls a cycle where the brachial cuff read approximately 62mmhg for map and clearsight was reading significantly higher.Halfway through the case, the clearsight monitoring was stopped so as to move the patient for the second part of the procedure.They disconnected the patient equipment.The anesthesiologist was working to get the brachial cuff reading connected.The edwards rep was connecting the clearsight finger cuffs.They were using a dual cuff monitoring mode up until this point, but went with the single finger cuff monitoring now.The finger cuff reading was higher that the brachial cuff reading.The edwards rep re-zeroed and started the finger cuff monitoring again, but had the same issue.It was running 30 point offset higher.They exchanged the suspect hrs device and the issue was resolved.The value readings were now much closer to the forearm cuff reading.The cardiac index and svr numbers were much better than during the first part of the case.It is unclear if this was by chance or due to the replacement of the hrs.There were no error messages or alarms noted.The exact inaccurate numbers are not available as the facility does not use electronic records.There was no inappropriate patient treatment reported.There was no patient harm or injury.

Manufacturer Narrative

One heart reference sensor was received for product evaluation.The hrs device was connected to a known good working clearsight system components for testing.With the bladder and sensor at the same height, the zero offset value was 25mmhg.There was an "out of range" error message that displayed when attempting to zero the device.The sensor did respond to differences in the bladder and sensor height when moved.It was determined that the hrs was out of calibration.It was unable to be re-calibrated as the eeprom was locked.With any hemodynamic monitoring readings can change quickly and dramatically.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make decisions.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.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.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to the complaint.

Manufacturer Narrative

Additional information has been obtained in regard to the product evaluation findings.The housings were removed from the device to perform a visual inspection.There were no visual abnormalities noted.The bladder looked normal and in the neutral position.There was no appearance of pressure build up.There was no indication of any oil leakage from the device.The wire solder joints on the sensor and the hdmi printed circuit board assembly were good.There were no visible defects on the sensor.The hdmi connector was good, no defects or abnormalities.The hdmi pcba was inspected and there were no defects or abnormalities.Further inspection was performed and no defect was found.

Manufacturer Narrative

A correction has been made to the occurrence date.Changed to (b)(6) 2020.The clinical logs are attempting to be obtained from the facility, but are not yet available.Once these have been received and reviewed a supplemental submission will be provided with the findings.

Manufacturer Narrative

The cause of the inaccurate values experienced by the customer could not be identified.No defects were found during the product evaluation.The diagnostic logs review did not confirm the reported incident.As per initial product evaluation, an "hrs out of range" error was observed during testing and the sensor was observed to be out of calibration.The device could not be re-calibrated because in manufacturing the eeprom is locked for security reasons.Further investigation was performed on the returned device and no anomalies/defects were identified.It is unknown why the hrs was observed to be out of calibration during initial product evaluation.The diagnostic log review found no evidence of an hrs "zeroing" issue or any faults/alerts that were identified.The logs do not confirm the customer's complaint.There was no indication or evidence of a manufacturing defect.Corrective action was not generated as the investigation found no defect identified.

• Brand Name: CLEARSIGHT HEART REFERENCE SENSOR
• Type of Device: EVHRS HEART REFERENCE SENSOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10979942
• MDR Text Key: 220979500
• Report Number: 2015691-2020-14934
• 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,Followup,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2021
• Device Model Number: EVHRS
• Device Catalogue Number: EVHRS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BRACHIAL CUFF, FINGER CUFF.