MAUDE Adverse Event Report: EDWARDS LIFESCIENCES IRVINE FORESIGHT IQ; CATHETER, OXIMETER, FIBER-OPTIC

Model Number	FSESLIQ
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	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the foresight sensor the total hemoglobin was off by more than 1 g.There was no allegation of patient injury.
Additional Manufacturer Narrative
Additional fda product codes include: dsb, plethysmograph, impedance.Dxn, system, measurement, blood-pressure, non-invasive.Fll, continuous measurement thermometer.Mud, oximeter, tissue saturation.Qaq, adjunctive predictive cardiovascular indicator.Qem, cerebral oximeter.Qms, adjunctive open loop fluid therapy recommender.Qnl, medium-term adjunctive predictive cardiovascular indicator.The device evaluation is anticipated.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
Per review of the images provided by the customer, it's confirmed image 1 shows hemosphere alta monitor displaying foresight thb as 6.8g/dl and image 2 shows arterial blood gas results with hb cpb as 8.5g/dl.The device was not returned for evaluation.Without the return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.A device history record review was unable to be completed as the lot number was not provided.

• Brand Name: FORESIGHT IQ
• Common Device Name: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): BD APM; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 24782754
• Report Number: 2015691-2026-13831
• Device Sequence Number: 12295479
• Product Code: DQE
• UDI-Device Identifier: 00690103219616
• UDI-Public: 00690103219616
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K242451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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: FSESLIQ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 04/18/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown