MAUDE Adverse Event Report: EDWARDS LIFESCIENCES IRVINE HEMOSPHERE ALTA; CATHETER, OXIMETER, FIBER-OPTIC

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	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional fda product codes include: qaq- adjunctive predictive cardiovascular indicator, mud- oximeter, tissue saturation, dxn- system, measurement, blood-pressure, non-invasive, dsb- plethysmograph, impedance, fll- thermometer, electronic, clinical, qms- adjunctive open loop fluid therapy recommender, qnl- medium-term adjunctive predictive cardiovascular indicator, qem- cerebral oximeter, dqk- computer, diagnostic, programmable.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.
Event or Problem Description
It was reported that during use of the alta cardiac monitor the blood temperature was incorrect.There was no alert or error message from the monitor.The monitor was displaying temperatures of 89 to 91 degrees.At that point it was not calculating co values either.The rep first replaced the cco cable in an attempt to troubleshoot, however the monitor again read low temperature with no alert but was calculating co numbers.Temperatures were confirmed by foley catheter.There was no patient injury.
Additional Manufacturer Narrative
One hemosphere alta monitor was returned for product evaluation.The customer report of inaccurate values was confirmed.When evaluated, measure bt current failed consistently on the functional tester.Removed the rear panel and found a screw sitting between two pins towards the top of the swan - ganz receptacle.The magnet in the connector was holding it there.After removing the screw, the swan interface tests passed.No damage was found.The bd apm investigator identified the screw as one used on the alta to secure the swan receptacle and all the other connectors on that side of the device.The device history record review was completed and the product passed without nonconformances.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.The report of inaccurate values was confirmed due to an electrical short.The electrical short was caused by a screw sitting between two pins towards the top of the swan - ganz receptacle.There was no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect that would have contributed to the reported event.

• Brand Name: HEMOSPHERE ALTA
• Common Device Name: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES IRVINE; 1 edwards way; irvine CA 82604
• Manufacturer (Section G): BD APM; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 23835470
• Report Number: 2015691-2025-10297
• Device Sequence Number: 21090165
• Product Code: DQE
• UDI-Device Identifier: 00690103217971
• UDI-Public: (01)00690103217971(11)250611
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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: 19Y0002059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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