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

Model Number	HEMOXSC100
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, when connecting the hemosphere oximetry cable to the patient, the svo2 (mixed venous oxygen saturation) values were 20 higher than expected.The values were compared with a blood gas analysis (abg) that indicated a value of 50, while the hemosphere oximetry cable showed a value of 70%.The cable was replaced with another one, and the values obtained were correct.No further information available.There is no allegation of patient injury.Patient demographics were unable to be obtained.
Additional Manufacturer Narrative
Upon the return of the product an investigation 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.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.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.
Additional Manufacturer Narrative
Added information to section d9 updated section h6 (impact code),h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).One hemosphere oximetry cable was received for a full examination.The report of inaccurate values was unable to be confirmed.Firstly, no defects were found during visual inspection.As received, the oximetry cable was connected to a kgu (known good unit) monitor and using a kgu (known good unit) swan ganz catheter and no issues were found.In addition, the diagnostic logs were extracted and further reviewed by the engineers, but no issues were found registered on the date of the event.Based on the logs review, there were values were showed on 3rd and 4th of march, but there were no issues registered and values were within range.Finally, the oximetry cable passed the functional test and run-in test successfully.Since no defect was found on the returned device, no cause could be determined.

• Brand Name: HEMOSPHERE FORESIGHT OXIMETER CABLE
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; one edwards way; irvine, CA 92614
• MDR Report Key: 21759638
• Report Number: 2015691-2025-02537
• Device Sequence Number: 8811660
• Product Code: DQK
• UDI-Device Identifier: 00690103196986
• UDI-Public: (01)00690103196986(11)201223
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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 Expiration Date: 01/06/2026
• Device Model Number: HEMOXSC100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown