MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE ADVANCED MONITORING PLATFORM, HEMOSPHERE FORESIGHT OXIMETER CABLE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number HEMFSM10

Device Problem Incorrect Measurement (1383)

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

Event Date 12/05/2023

Event Type  malfunction  

Event Description

As reported, during preventive maintenance at the local service provider of this hemosphere fore sight module.The cable does not meet criteria since sto2 value was 52% (65% should be).There was no patient involved.The device was available for evaluation.As per product evaluation results at a certified evaluation center, during visual inspection it was observed physical damage at cable of channel 2.The fsm was plugged into a known good tom connected to a known good hem1.Sto2 simulators were connected and sto2 values were lower than expected at channel 2.The displayed value was 54% instead of 65%.

Manufacturer Narrative

Engineering evaluation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results.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.

Manufacturer Narrative

Added information to section h6 (type of investigation) updated section h6 (investigation findings) and h6 (investigations conclusions).The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.H3: based on the initial evaluation the sto2 values provided by the device were lower than expected.The device was further evaluated by the original manufacturer.The report could be confirmed as a suspected relation to the issue found could be identified.This hemfsm10 was connected to a known working hemosphere system and began monitoring sto2 simulators.They read 65%.Moving and bending the cables did not cause any fluctuation in the sto2 readings.Foreign material was found inside the connector of sensor cable 2 and there was slight damage to the devices lower enclosure where cable 2 enters.The cable and enclosure were replaced.Physical damage and contamination was identified in sensor connector channel 2 where the lower sto2 values were observed during the initial product evaluation.The issue could not be replicated during further evaluation at the original manufacturer, however, a root cause of the issue of the damage and contamination was likely related to unintended use of the device.No manufacturing non-conformance or labeling/ifu inadequacies were identified.

• Brand Name: HEMOSPHERE ADVANCED MONITORING PLATFORM, HEMOSPHERE FORESIGHT OXIMETER CABLE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): IRVINE; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 18674614
• MDR Text Key: 335128043
• Report Number: 2015691-2024-00883
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HEMFSM10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• Type of Device Usage: Reuse
• Patient Sequence Number: 1