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	10/23/2024
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 with pump pressure maintained at 58-60 mmhg all the procedure), cerebral adaptative index (cai) tile was high (remained in 70 with minor fluctuations) since it was not updated with the live map value.The live map value was correctly displayed on the monitor all the time.This problem is not experienced when patient is not on bypass (pulsatile mode); after non pulsatile mode was disabled, the map reported on cai was more realigned with live map value.There was no alarm nor error message displayed.There was no allegation of patient injury.The device was not available for evaluation.
Additional Manufacturer Narrative
Updated sections h6 (type of investigation, investigations findings, investigations conclusions).The hemosphere alta advanced involved in this case was not returned for evaluation, as this is a tmr.Further investigation was completed by the engineers in the manufacturing site.Based on this assessment, investigation identified that this issue was caused by a software defect in the skynet main gui (v2.0.5) software which is part of alta 2.0 monitor.Investigation was initiated under apm internal software defect system.This issue is planned to be fixed in version 2.6.Internal actions have been initiated by the software change control group (sccg) to address this software issue.

• 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: 20681720
• Report Number: 2015691-2024-08612
• Device Sequence Number: 20693111
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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
• Device Lot Number: 19Y0000216
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/27/2024
• 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