MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE ALTA ADVANCED MONITORING PLATFORM; CATHETER, FLOW DIRECTED

Model Number	ALTAALL1
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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.
Event or Problem Description
As reported, during this target market release (tmr) on a mitral valve replacement with pseudoaneurysm case, the total hemoglobin (thb) value was higher (10.7 g/dl) on the hemosphere alta monitor when compared to the value obtained from the blood gas sample (7.9 g/dl).The values trend remained straight and constant during the whole procedure even if the sensor may not stick perfectly.After recalibrating the monitor, thb values matched to the ones provided by the blood gas.There was no error message displayed.The patient was not treated according to the inaccurate values.There was no patient movement.There was no allegation of patient injury.The device was not available for evaluation since this is a tmr.
Additional Manufacturer Narrative
Updated section h6 (component code), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).The product was not available for evaluation, however an image was provided for review.Based on the image evaluation, the image confirmed the alleged complaint as it was observed that the total hemoglobin (thb) value measured by the monitor was higher than the value from the blood gas sample entered by the user.However, product nonconformance was unable to be confirmed as the device was not returned.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.

• Brand Name: HEMOSPHERE ALTA ADVANCED MONITORING PLATFORM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine, ca CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 22727685
• Report Number: 2015691-2025-06375
• Device Sequence Number: 21118098
• Product Code: DYG
• UDI-Device Identifier: 00690103217957
• UDI-Public: (01)00690103217957(11)241212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K242451
• 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,Company Representative
• Initial Reporter Occupation: Physician
• 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 Model Number: ALTAALL1
• Was Device Available for Evaluation?: No
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2024
• 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