MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE OXIMETRY 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	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Added information to section h2 (type of follow-up).Updated section g3 (date received by manufacturer), g6 (type of report), h3 (device evaluated by manufacturer), h6 (component code, type of investigation, investigation findings, investigation conclusions).The device was received for evaluation.Complaint was not confirmed since the inaccurate values were non-reproducible.However, another issue was found.Visually, it was detected that the optical housings were damaged.As received, the device was plugged into a known good unit (kgu) monitor with a kgu swan-ganz catheter.The device was recognized but it failed the svo2 test in the "in vitro calibration" step.Issue was solved by using a kgu base plate pre-amp.Then, the svo2 test could be performed, obtaining a value of 80% stable, as expected.Based on further investigation by the engineers team, the inaccurate values could not be replicated, therefore a definite root cause was unable to be established.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.Based on this assessment, no further action is required at this time, however, all events will continue to be reviewed and monitored.
Additional Manufacturer Narrative
The product was returned for analysis; however, it has not been evaluated yet.Upon the evaluation of the product 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.
Event or Problem Description
As reported, this hemosphere oximetry cable provided different measurements than expected according to physiological state of the patient.The issue was solved replacing the device.There was no further information available.There was no allegation of patient injury.

• Brand Name: HEMOSPHERE OXIMETRY 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 ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 21122449
• Report Number: 2015691-2025-00213
• Device Sequence Number: 15319342
• Product Code: DQK
• UDI-Device Identifier: 00690103196986
• UDI-Public: (01)00690103196986(11)201218
• 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,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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?: Yes
• Date Returned to Manufacturer: 12/23/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2020
• 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