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

Model Number	HEM1
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	02/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during use of the hem1, the co/ci values were low compared to those on a different monitor.The nurse changed the hem1, kept the cable and the module attached to the swan-ganz catheter and the new monitor showed more normal values that more accurately reflected the patient's condition.There was no allegation of patient injury.The device is available for return.
Additional Manufacturer Narrative
Additional fda 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 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.
Additional Manufacturer Narrative
One hemosphere monitor was returned for evaluation.The customer report of inaccurate values was not confirmed.The monitor was connected to a known working swan-ganz, cco cable, and a cco simulator.The readings were the expected values and did not lower during use.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Based on the available information there is no evidence that supports or confirms the reported event of inaccurate values is associated to a manufacturing design defect.Since the issue of inaccurate values could not be replicated during the evaluation, the root cause cannot be determined.The hemosphere operators manual states that inaccurate cardiac output measurements may be caused by incorrect placement or position of the catheter and excessive variations in pulmonary artery blood temperature.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 a part of the monthly review.

• Brand Name: HEMOSPHERE
• Common Device Name: CATHETER, OXIMETER, FIBEROPTIC
• 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: 21364939
• Report Number: 2015691-2025-00951
• Device Sequence Number: 20945254
• Product Code: DQE
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)190814
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K163381
• 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): 04/03/2025

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 Expiration Date: 08/19/2024
• Device Model Number: HEM1
• Device Lot Number: 13821162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown