MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER; OXIMETER, TISSUE SATURATION

Model Number 01-06-3000

Device Problems Incorrect Measurement (1383); Output Problem (3005)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results as well as the device history record.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 this monthly review.

Event Description

It was reported that, when using this foresight elite tissue oximeter during the selective cerebral perfusion (scp) surgery, the sto2 values of the channel 1 and channel 2 would not rise in parallel despite the blood flowing to the three branches of the aortic arch (brachiocephalic trunk, common carotid artery, and subclavian artery).Therefore, it was assumed that the monitor had problems.It is unknown what the exact values were.There was no patient injury reported.The exact incident date is unknown; so, defaulting to aware date.

Manufacturer Narrative

The device history record was reviewed; no related non-conformances were found.

Manufacturer Narrative

The foresight elite tissue oximeter was returned for evaluation.The reported issue was not confirmed by the evaluation.The monitor was powered on and connected a patient simulator.Both channels read the same reading.The patient simulator was ran for over an hour and both readings stayed matching.During the functional testing the device failed step 14.4.1 1 - wire of the device test.Channel 7 was not detected as a temperature sensor.This is not related to the reported issue.The device passed after reseating the controller boards to the backplane board.The software version was upgraded from 4.1.0 to 4.5.8 and 2.4.1 to 2.5.3.With any hemodynamic monitoring, patient parameters can change quickly and dramatically.Tissue oximetry readings should correlate with the patient¿s clinical manifestations.These devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.These devices are typically used in intensive care units or operating rooms where patients are closely monitored.It is unknown whether any user or procedural factors contributed to this reported event.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.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
• Type of Device: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9578900
• MDR Text Key: 194679389
• Report Number: 2015691-2020-10147
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/19/2019

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: 07/16/2019
• Device Model Number: 01-06-3000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/11/2020
• Supplement Dates Manufacturer Received: 01/29/2020; 06/18/2020; 07/23/2020
• Supplement Dates FDA Received: 03/13/2020; 07/07/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1