MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE; CATHETER, OXIMETER, FIBEROPTIC

Model Number	HEMOXSC100
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes include: dqk: computer, diagnostic, programmable qaq: adjunctive predictive cardiovascular indicator mud: oximeter, tissue saturation dxn: system, measurement, blood-pressure, non-invasive dsb: plethysmograph, impedance qms: adjunctive open loop fluid therapy recommender fll: thermometer, electronic, clinical.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 results become available.A device history record review was completed and documented that the device met all specifications upon distribution.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.
Event or Problem Description
It was reported that inaccurate scvo2 values were observed during use.The issue was resolved by replacing the cable.No treatment was performed based on the incorrect values.They attempted to obtain information such as indicated value, expected value, data log, whether any error message was displayed or whether the values were affected by the patient condition, but unavailable.There were no patient complications reported.
Additional Manufacturer Narrative
One hemosphere oximetry cable was returned for evaluation.The reported issue regarding inaccurate values was not confirmed through the evaluation.An error message fault: oximetry cable malfunction was found.The functional test was performed on the unit, and it failed the test.There was no physical damage, but an internal failure was confirmed.The reported issue could not be confirmed; therefore the root cause could not be determined.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.

• Brand Name: HEMOSPHERE
• Common Device Name: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES IRVINE; one edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; one edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 20656076
• Report Number: 2015691-2024-08531
• Device Sequence Number: 4412671
• Product Code: DQE
• UDI-Device Identifier: 00690103196986
• UDI-Public: (01)00690103196986(11)220811
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

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: HEMOXSC100
• Device Lot Number: 16613988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown