MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE; HEMOSPHERE ADVANCED MONITOR

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	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The device history review was completed and 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.The device history review has been completed and no related non-conformances were found.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 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.
Event or Problem Description
It was reported that the hemosphere monitor is giving incorrect svo2 values that do not correlate with the patient condition or lab work.The staff recalibrated and exchanged out cables with no resolve.They exchanged to a new hemosphere monitor with the same cables and the svo2 values were correct.This was during use.There is no patient injury.
Additional Manufacturer Narrative
Multiple attempts were made to secure return of the device; however, the device was not sent back for evaluation.Without the return of the device, it is not possible to determine if there was damage or a defect that existed on the unit that could have contributed to the event.It is not known if any procedural factors may have contributed to the reported issue.As the complaint could not be confirmed, there is not sufficient evidence to determine a root cause.
Additional Manufacturer Narrative
One hemosphere monitor was returned for evaluation.Customer complaint of incorrect sv02 values was not confirmed.The svo2 reading remained stable at 82% plus or minus 3% for 15 minutes on both smart cable ports 1 and 2.The alarm light lid and diffuser have been separated from the bezel and the bezel is cracked in the corner of where the alarm light lid sits.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Since the complaint could not be confirmed, a root cause could not be identified.

• Brand Name: HEMOSPHERE
• Common Device Name: HEMOSPHERE ADVANCED MONITOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; one edwards way; irvine, CA 92614
• MDR Report Key: 21862122
• Report Number: 2015691-2025-03008
• Device Sequence Number: 20807806
• Product Code: DQE
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)191219
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2025

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: 01/13/2025
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 05/08/2025; 07/24/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/27/2025; 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2019
• 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