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 06/24/2022

Event Type  malfunction  

Event Description

It was reported that the hemosphere instrument, hem1 displayed fluctuating and intermittent st02 values, per the physician.This occurred during patient use.The a2 r value stayed steady, with values from 88 to 89 during the case.The a1 l value fluctuated between 65 and 88.It changed every few seconds.After a few minutes of the displayed values, the a1 stopped generating values.After several minutes the cycle started again.The edwards representative inquired of the physician if a fault message was displayed for this event and that could not be confirmed.The products involved in this event are the hem1, foresight sensor, foresight elite module and hemosphere tissue oximeter module.There was no patient harm or injury.There was no inappropriate patient treatment administered.The patient demographics were requested but not provided.

Manufacturer Narrative

The hemosphere instrument is expected to be returned but has not yet arrived for evaluation.Once it has arrived and has been evaluated, the findings will be submitted in a supplemental submission.The device history record review was completed and all manufacturing inspections passed with no non conformances.The submission numbers of the other products involved in this event will be submitted when available.

Manufacturer Narrative

The hemosphere instrument was returned for evaluation.A known good working hemtom and foresight module were connected to the suspect hem1 for testing.The module was placed in slot 2 and the st02 readings were able to be taken appropriately with no error messages.A patient simulator was also connected for testing.The expected st02 value was displayed appropriately.When the hemtom was moved to slot 1 to continue testing, there was a "hardware failure" fault message that occurred.A known good working sg module was then placed in slot 1 and the "hardware failure" fault message occurred again.It was determined that there was an issue with the modules board.It was replaced and installed.Testing continued with the hemtom and sgm being placed in slot 1 and there were no further error messages with the replacement modules board installed.The diagnostic logs were downloaded.The event date of 7/21/2022 was not found in the logs.The reported issue was not confirmed.

Manufacturer Narrative

The report id numbers for the other components linked to this same event are, 2015691-2022-07153, 2015691-2022-07154, 2015691-2022-07156.

• 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: 15161285
• MDR Text Key: 302476153
• Report Number: 2015691-2022-07152
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)211015
• 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: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2022

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 Model Number: HEM1
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2022
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: 08/03/2022; 09/08/2022
• Supplement Dates FDA Received: 08/11/2022; 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2021
• 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