MAUDE Adverse Event Report: EDWARDS LIFESCIENCES IRVINE 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	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional fda product codes include: 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.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 hemosphere monitor, an svo2 error message appeared and it would not give correct co numbers.The user tried to change the cables to resolve the issue but it did not work.A new monitor worked as expected.There was no patient injury.
Additional Manufacturer Narrative
The device was not returned for 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 performed and no manufacturing non conformances were identified associated to the reported malfunction.The instructions for use contains the following precautions: inaccurate cardiac output measurements may be caused by: incorrect placement or position of the catheter, excessive variations in pulmonary artery blood temperature, anatomical abnormalities, excessive patient movement, electrocautery or electrosurgical unit interference, or rapid changes in cardiac output.

• Brand Name: HEMOSPHERE
• Common Device Name: CATHETER, OXIMETER, FIBEROPTIC
• 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: 22749475
• Report Number: 2015691-2025-06450
• Device Sequence Number: 8607138
• Product Code: DQE
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)200530
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K163381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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: 06/07/2025
• Device Model Number: HEM1
• Device Lot Number: 13824912
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown