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

Model Number	ALTAALL1
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.No product was returned for evaluation.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.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.
Event or Problem Description
As reported, during this target market release (tmr) with this hemosphere alta monitor, in a patient in bypass (non pulsatile mode), cerebral adaptative index (cai) map value during bypass (in non-pulsatile mode) was inaccurate and did not correlate with the map readings from the arterial line.Additionally, clinician said during the night there was a discrepancy of approximately 2 g/dl between the thb displayed and the actual thb.The parameter was still showing "cal" has it had been previously calibrated; although the clinician stated that the recalibration flag indicating a recalibration needed had not been shown previously.There was no allegation of patient injury.
Additional Manufacturer Narrative
Updated sections h6 (component code), h6 (investigation findings) and h6 (investigation conclusions).Added information to h6 (type of investigation).The hemosphere alta advanced involved in this case was not returned for evaluation as this is a target market release.Based in further investigation it was identified that this issue was caused by a software defect in the alta 2.0 monitor.Pra has been generated to address this issue and internal actions are being taken to correct the issue in future version.

• Brand Name: HEMOSPHERE ALTA ADVANCED
• Common Device Name: ALTA 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 20732707
• Report Number: 2015691-2024-08755
• Device Sequence Number: 18218748
• Product Code: DQK
• UDI-Device Identifier: 00690103217957
• UDI-Public: (01)00690103217957(11)240826
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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: 10/28/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2024
• 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