MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE ALTA ADVANCED MONITORING PLATFORM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ALTAALL1
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a liver transplant procedure in a hyperdynamic patient, the hemosphere alta monitor connected to a swan-ganz iq catheter displayed right ventricle cardiac output (rvco) around 3 l/min, assessed as low compared to intermittent cardiac output (ico), which was 6 l/min.Intermittent co measurements were more clinically consistent with the patient's condition.Right ventricle pressure waveform and swan-ganz catheter position were considered correct.The same issue occurred in the intensive care unit (icu) the following day with the same patient.Patient management was guided by the values deemed most clinically appropriate.There was no allegation of patient injury.The device was available for evaluation.Patient demographic information was not available.
Additional Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.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.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 Manufacturer Narrative
Added information to section h6 (type of investigation) updated section h6 (investigation findings) and h6 (investigations conclusions).Finally, the device was not received for evaluation.Without return of the product, a complete investigation of the reported event is unable to be performed.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.Log files were provided for review, however the investigation was unable to be completed due to not correct log type.The root cause was not able to be determined.

• Brand Name: HEMOSPHERE ALTA ADVANCED MONITORING PLATFORM
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 24256442
• Report Number: 2015691-2026-10787
• Device Sequence Number: 8346356
• Product Code: DQK
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K252533
• 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: Other
• 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: ALTAALL1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 04/18/2026; 07/30/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 04/21/2026; 07/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown