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	05/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional fda product codes include: mud- oximeter, tissue saturation.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 evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.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.
Event or Problem Description
It was reported that during use of the foresight module, it was displaying sto2 values that were higher than expected.The clinician changed sensors, the cable, and sensor placement but was unable to resolve the issue.A new module was used to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
One fore-sight elite module was returned for evaluation.When the module was connected to a known working hemosphere system it gave expected and steady sto2 readings.Moving and bending the cables did not cause any faults or changes in the readings.Monitored sto2 simulators for over 2 hours without any variation of the readings.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.The report of inaccurate values could not be confirmed, therefore a root cause could not be established.Based on the available information and previous evaluations, there is no evidence that supports or confirms the failure mode is associated to a manufacturing/ design defect.

• Brand Name: HEMOSPHERE FORESIGHT MODULE
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): EDWARDS LIFESCIENCES IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 22136577
• Report Number: 2015691-2025-04386
• Device Sequence Number: 7445423
• Product Code: MUD
• UDI-Device Identifier: 00690103208573
• UDI-Public: (01)00690103208573(17)270628(11)220629
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: 21107272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown