MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE ALTA

Model Number	ALTACR1
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use, the hemosphere alta cardiac had oximetry value out of range.It was confirmed that there was no patient injury or harm associated with the reported event.No other information was reported.
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.The device history record review has not yet been completed.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 a part of the monthly review.
Additional Manufacturer Narrative
A product evaluation was completed on the returned hemosphere alta cardiac.The customer report on "value out of range" was not confirmed.Calibrated an oximetry cable on the bottom smart cable port and monitored for 1 hour.The svo2 reading remained stable at 80%.Was able to calibrate an oximetry cable and obtain a normal svo2 reading of 80% on the remaining smart cable ports.No damage was found.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.The reported issue was not able to be confirmed.During product evaluation, there was no defect found.Based on the available information there is no evidence that supports or confirms the failure mode is associated with a manufacturing or design defect.A device history record review was completed and documented that device met all specifications upon distribution.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 a part of the monthly review.After further review and thorough device evaluation.It has determined that the suspect device did not experience "value out of range".We can confirm that the suspect device operated and functioned as intended.Based on all evidence received, this initial report is considered retracted.

• Brand Name: HEMOSPHERE ALTA
• Common Device Name: HEMOSPHERE ALTA
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 22118208
• Report Number: 2015691-2025-04319
• Device Sequence Number: 4171758
• Product Code: DXN
• UDI-Device Identifier: 00690103217971
• UDI-Public: (01)00690103217971(11)240930
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Company Representative
• Initial Reporter Occupation: Other
• 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: ALTACR1
• Device Lot Number: 19Y0000446
• Was Device Available for Evaluation?: Yes
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown