MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FORESIGHT ELITE ABSOLUTE TISSUE OXIMETER; FORESIGHT ELITE MONITOR

Model Number 01-06-3000

Device Problems Incorrect Measurement (1383); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

The fse monitor is expected to be returned for evaluation.Once the evaluation has been completed the findings will be submitted in a supplemental report.The device history record review was reviewed; no related non-conformances were found.No previous related record of servicing.No escalation is required.Once the evaluation results are available they will be submitted in a supplemental report.There are two other occurrences with this same fse monitor.The mdr submission numbers will be provided when available.

Event Description

It was reported that there were inaccurate values observed with the foresight elite monitor.This occurred during patient monitoring.Pediatric patient, 11kg, cerebral/somatic renal monitoring.Fontan, high hematocrit in the 40¿s.The clinicians stated that both cerebral and renal values dropped 20%.Also that the numbers were unresponsive to changes in physiology and interventions.There was increased pump flow and psaco2 did not change the values.Baseline values were renal 78 and cerebral 74.The clinicians powered down the monitor and re-started.Upon re-start the renal values increased from 62 to 71, l&r values were about 10% higher.The cerebral values increased from 50 to 71, a 40% increase.The clinician stated the values then correlated more closely with the patient changes after restarting the monitor.There was no patient harm or injury.

Manufacturer Narrative

The fse monitor is expected to be returned but has not yet arrived.When the product evaluation findings are available a supplemental report will be submitted.There were two other occurrences with this same fse monitor.Submission numbers are 2015691-2020-12664 and 2015691-2020-12889.

Manufacturer Narrative

One foresight elite tissue oximeter monitor was received for product evaluation.The unit powered up successfully and was attached to a known good working foresight elite preamp cable simulator for testing.The patient settings that were retained in the system were for a pediatric patient and they were tested first.Channel 1 was the right head channel and channel 2 was the right side of the body.Channel 1 read st02 as 59 and channel 2 read st02 as 60.The system was left to run for over an hour and there were no changes to the readings.The patient settings were changed to adult with an attached additional simulator.The channels 1 and 3 were for the right head and channels 2 and 4 were for the left head.Channels 1 and 2 read as 59 and channels 3 and 4 read as 60.The simulators were left to run for 5 hours of testing.The readings remained steady and in range throughout testing.There were no error messages displayed.The foresight elite tech support system test was performed and the unit passed the test.There was no defect found.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

Further investigation of the foresight elite monitor was performed by the edwards r&d engineers.The unit was powered on and left to run continuously for five days.There were various tests performed to try to replicate the reported issue.The issue could not be reproduced.The hard drive on the unit was inspected and there was no data available.The unit had been refurbished and cleaned inadvertently prior to this evaluation.There was no issue found.There is no further investigation to be done on this unit.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: FORESIGHT ELITE ABSOLUTE TISSUE OXIMETER
• Type of Device: FORESIGHT ELITE MONITOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10317825
• MDR Text Key: 201064751
• Report Number: 2015691-2020-12663
• Device Sequence Number: 1
• Product Code: MUD
• Combination Product (y/n): N
• PMA/PMN Number: K143675
• 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: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01-06-3000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 11