MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE; HEMOSPHERE ADVANCED MONITOR

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	07/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were inaccurate values with the hemosphere monitor during patient use.The cardiac output numbers that displayed on the unit were inaccurate compared to the cardiac output numbers from the blood draw.The cardiac output number was approximately 4 throughout the surgery.On arrival to the surgical intensive care unit the cardiac number was less than 2.The clinicians checked the patient height and weight and demographic information that was entered to confirm it was correct.They did a fick and the cardiac output results were between 3 and 4.They converted the swan catheter to manual thermodilution and the results were 3 to 4.They performed a cable test on the cable and it passed the test.They exchanged for a different hemosphere unit and the cardiac output results were now between 3 and 4.There was no inappropriate patient treatment administered.The patient demographics were requested and are not available.The patient has been discharged.There was no patient harm or injury.
Additional Manufacturer Narrative
The hemosphere has arrived for product evaluation.The evaluation is not completed.Once the results are available, they will be sent in a supplemental submission.The device history record review was completed and all manufacturing inspections passed with no non-conformances.Additional product codes, 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.
Additional Manufacturer Narrative
The hemosphere was returned for product evaluation.The unit was connected to a known good working swan ganz cable and continuous cardiac output simulator to perform system verification testing.It was found that the cardiac output values remained within appropriate parameters for the entire four hours of run time and testing.There were no error messages that displayed.There was no failure identified.The reported issue was not confirmed.The engineering evaluation was completed.Since the issue was not confirmed, there is not sufficient evidence to determine if this complaint was related to manufacturing, design, or labeling.It is not known if any procedural factors may have contributed to the event.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: HEMOSPHERE ADVANCED MONITOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 19986728
• Report Number: 2015691-2024-06144
• Device Sequence Number: 17949544
• Product Code: DQE
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)190829
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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: 09/07/2024
• Device Model Number: HEM1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2024
• 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: 07/29/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown