MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	HEM1
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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, during use, that a hem1 monitor displayed co numbers that were presumed to be wrong.Due to issue, customer stopped using the monitor.There were no patient injuries.
Additional Manufacturer Narrative
Multiple attempts were made to secure return of the device however the customer has not responded nor sent the device back for evaluation.Without the 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.However, an investigation was initiated to assess for any manufacturing related processes which could be correlated to the lot number.Reviews of the device history record revealed no indication that a manufacturing nonconformance contributed to the reported complaint.Based on available information, there is not sufficient evidence to suggest that the device related issue resulted from any of the specified factors.
Additional Manufacturer Narrative
It was previously reported that the device would not be returned.However, the device was eventually returned.A product evaluation was completed on the returned hemosphere monitor.The reported event of inaccurate values was unable to be confirmed.The monitor was connected to a known working swan ganz module and began monitoring a continuous cardiac output (cco) simulator.Devices were tested for 2 hours and the cardiac output (co) numbers remained accurate.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.A device history record review was completed and documented that device met all specifications upon distribution.The complication section of the hemosphere operator's manual contains a statement regarding inaccurate cardiac output measurements.Possible causes may be incorrect placement or position of the catheter, excessive variations in pulmonary artery blood temperature.Some examples that cause blood temperature variations include, but are not limited to: status post cardiopulmonary bypass surgery, centrally administered cooled or warmed solutions of blood products, and use of sequential compression devices.Additionally, clot formation on the thermistor, anatomical abnormalities (for example, cardiac shunts), excessive patient movement, electrocautery or electrosurgical unit interference, and rapid changes in cardiac output.

• Brand Name: HEMOSPHERE
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 00610
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 20416778
• Report Number: 2015691-2024-07713
• Device Sequence Number: 18198269
• Product Code: DQK
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)200608
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K223865
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2025

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
• Device Expiration Date: 06/11/2025
• Device Model Number: HEM1
• Device Lot Number: 13825187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: 11/18/2024; 05/15/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 11/25/2024; 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2020
• 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