MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE; CATHETER, OXIMETER, FIBEROPTIC

Model Number	HEM1
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	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot not 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 part of this monthly review.Additional product codes: dqk: computer, diagnostic, programmable.Qaq: adjunctive predictive cardiovascular indicator.Mud: oximeter, tissue saturation.Dxn: system, measurement, blood-pressure, non-invasive.Dsb: plethysmograph, impedance.Qms: adjunctive open loop fluid therapy recommender.Fll: thermometer, electronic, clinical.Olw: index generating electroencephalograph software.
Event or Problem Description
It was reported that during use of this hemosphere monitor, it was suspected of providing incorrect svr.The cable was tried on another monitor and worked.Switching out the monitor for another monitor corrected the issue.There was no patient injury.
Additional Manufacturer Narrative
The device was not returned for product evaluation.Without 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.The device history record review was completed and the product passed without nonconformances.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.As no device was returned, a product non-conformance or device failure could not be confirmed and no root cause could be determined.The instructions for use contains the following warnings: possible causes of inaccurate values may be incorrect placement or position of the catheter, excessive variations in pulmonary artery blood temperature.Additionally, clot formation on the thermistor, anatomical abnormalities (for example, cardiac shunts), excessive patient movement, electrocautery or electrosurgical unit interference, and rapid changes in cardiac output.

• Brand Name: HEMOSPHERE
• Common Device Name: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 23855967
• Report Number: 2015691-2025-10380
• Device Sequence Number: 13297930
• Product Code: DQE
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: PREMARK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2026

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: HEM1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 02/10/2026; 07/17/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/12/2026; 07/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• 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