MAUDE Adverse Event Report: EDWARDS LIFESCIENCES IRVINE HEMOSPHERE FORESIGHT MODULE; OXIMETER, TISSUE SATURATION

Model Number	HEMFSM10
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during use, the hemosphere foresight module displayed inaccurate values.The expected values are typically in the 55-65 range.The values displayed would dip down to the 35-45 but only on the patient's right side.The customer changed the disposable foresight sensors stickies and experienced the same issue.When the hemosphere foresight module was replaced, the issue resolved.There were no error messages.There was no patient injury.
Additional Manufacturer Narrative
Additional fda product codes include: dqk- computer, diagnostic, programmable, dqe- catheter, oximeter, fiber-optic, qaq- adjunctive predictive cardiovascular indicator, dxn- system, measurement, blood-pressure, non-invasive, dsb- plethysmograph, impedance, qms- adjunctive open loop fluid therapy recommender, fll- thermometer, electronic, clinical.The device has been returned; however the product evaluation has not been completed.A supplemental report will be forthcoming when the investigation is completed.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.
Additional Manufacturer Narrative
One model hemosphere foresight module was returned for product evaluation.The customer report of inaccurate values was not confirmed.The foresight module was connected to a known working hemosphere monitor and tissue oximetry module.It was able to monitor sto2 simulators, for over an hour, with no errors and the readings were accurate.Moving and bending the cables did not cause any change in the readings.No physical damage was found to the cables.The failure was unable to be replicated.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to this complaint.As the complaint could not be confirmed no root cause could be identified.The device history record review was completed and no related non-conformances were found.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.

• Brand Name: HEMOSPHERE FORESIGHT MODULE
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): EDWARDS LIFESCIENCES IRVINE; 1 edwards wau; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 21619689
• Report Number: 2015691-2025-01971
• Device Sequence Number: 8510678
• Product Code: MUD
• UDI-Device Identifier: 00690103208573
• UDI-Public: (01)00690103208573(17)270201
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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
• Operator of Device: Health Professional
• Device Model Number: HEMFSM10
• Device Lot Number: 21104938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown