MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT; HEMOSPHERE MONITOR

Model Number HEM1

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2021

Event Type  malfunction  

Event Description

It was reported that low sto2 values were displayed on a hemosphere monitor prior to a product demonstration in the edwards booth at a medical conference.The foresight sensors had been placed on two volunteer foreheads and the cerebral oximetry readings were within normal limits.However sensors had also been placed on their forearms and the somatic tissue oximetry readings were in the 30 to 40 percent range when the expected values were 60 to 80 percent.Troubleshooting included applying sensors to their upper arms as well as placing sensors on another edwards employee calf but the same issue occurred.A total of three hemosphere monitors were used during troubleshooting including the original monitor.The monitors are all designated as demo units and each of them had windows 10 and foresight 2.0 software installed.After additional discussion with the product manager and engineer who were present it was believed that the ambient light of the conference surroundings were somehow interfering with the readings.The data logs from the monitors were downloaded.After returning from the conference the source of the issue remained inconclusive so the data logs were given to engineering for review.After review of the logs engineering discovered that the issue was not due to the ambient lighting and a complaint was opened for further investigation into a root cause.The affected hemosphere monitors and use of the product on the volunteers and edwards employees was for demonstration purposes only.Therefore there was no injury and no treatment was provided and or withheld as a result of the inaccuracies.

Manufacturer Narrative

The product will not be returned as the diagnostic logs will be reviewed.When the findings are available a supplemental submission will be sent.The device history record review has not been completed.When the findings are available a supplemental submission will be sent.There are 3 hem1 monitors involved in this event.When the mdr submission numbers are available they will be provided.The udi number is (b)(4).

Manufacturer Narrative

For the three hemosphere instruments involved, please refer to these report id numbers: 2015691-2021-06747, 2015691-2021-06748, and 2015691-2021-06749.The device history record review was completed and all inspections passed with no non-comformances.H3 other text : log files to be reviewed.

Manufacturer Narrative

After engineering evaluations were performed, engineers ruled out the monitors and there is no associated issue with them.H3 other text : logs were analyzed.

• Brand Name: HEMOSPHERE INSTRUMENT
• Type of Device: HEMOSPHERE MONITOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; one edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 12972385
• MDR Text Key: 282041078
• Report Number: 2015691-2021-06748
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)200229
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2022

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 Model Number: HEM1
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 12/09/2021; 12/13/2021
• Supplement Dates FDA Received: 12/22/2021; 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2020
• 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
• Treatment: FORESIGHT SENSORS