MAUDE Adverse Event Report: EDWARDS LIFESCIENCES IRVINE HEMOSPHERE ALTA ADVANCED; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number	ALTAALL1
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	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional fda product codes include: dsb plethysmograph, impedance qms- adjunctive open loop fluid therapy recommender dqe- catheter, oximeter, fiber-optic dqk- computer, diagnostic, programmable mud- oximeter, tissue saturation fll- thermometer, electronic, clinical qaq- adjunctive predictive cardiovascular indicator.No product will be returned for evaluation.Without return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.The device history record review was completed and all manufacturing inspections passed with no non conformances.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 the monthly review.
Event or Problem Description
It was reported, that during use, the map on the cai tile displayed on this hemosphere alta monitor was inaccurate.The map displayed in the map parameter tile was around 85 while cai map was 44.The cai map did update and change over time but continued to stay around half of the expected map value.This issue occurred after the pressure cable became inadvertently disconnected, during cardiopulmonary bypass.To troubleshoot, the rep attempted to disconnecting & reconnecting all cable connections with no success.There was no patient injury and the device will not be returned as it is still in use.

• Brand Name: HEMOSPHERE ALTA ADVANCED
• Common Device Name: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 21619855
• Report Number: 2015691-2025-01972
• Device Sequence Number: 8515712
• Product Code: DXN
• UDI-Device Identifier: 00690103217957
• UDI-Public: (01)00690103217957(11)240927
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2025

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
• Device Lot Number: 19Y0000363
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2024
• 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