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

Model Number	ALTAALL1
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during this target market release (tmr), in this hemosphere alta monitor, the lactated ringers bolus administered with the afm was tracked with delay.Therefore, sv (stroke volume) value and blue line trend on the 10-trend screen was not updated and did not reflect volume changes in patient.It was correctly tracked in the clinical tools screen and there was no more bolus administered as consequence of this issue.There was no allegation of patient injury.There will be no product return as this is a tmr.
Additional Manufacturer Narrative
The product is not expected to be returned for analysis.An investigation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results.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).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.The manufacturing records were reviewed for the serial number involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Based on the available information there is not sufficient evidence to suggest that the device related issue resulted from incorrect/inadequate labeling/ifu/training manual, use error, or patient/procedural factors.
Additional Manufacturer Narrative
An image was provided for review.The image confirms the allegation of the customer report.However, the issue was investigated and it was determined that the system behaved as expected.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation).Updated section h6 (investigation findings) and h6 (investigations conclusions).

• 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; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 20757455
• Report Number: 2015691-2024-08836
• Device Sequence Number: 18457446
• Product Code: DQK
• UDI-Device Identifier: 00690103217957
• UDI-Public: (01)00690103217957(11)240904
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K232294
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/19/2025

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 03/11/2025; 05/14/2025; 05/16/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 03/12/2025; 05/16/2025; 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown