MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE; CLEARSIGHT MODULE

Model Number	HEMCSM10
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	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for return but has not yet arrived for evaluation.When it has arrived and has been evaluated the findings will be sent in a supplemental submission.The device history record review is pending.When it has been completed the results will be sent in a supplemental submission.Additional product codes, dqe, qaq, mud, dsb, qms, fll, dxn.
Event or Problem Description
It was reported during use that there were inaccurate blood pressure values with the clearsight module.The displayed numbers were 20 to 40 points different from the blood pressure cuff reading.The clearsight reading would stop and a fault message of "pump malfunction" was displayed.When this occurred, they would have to restart the monitor.The pump unit was ruled out as a suspect device as when it was replaced the issue still occurred.The clearsight module was replaced for a different one and then everything worked without further incident.There is no physical damage seen on the module.There was no inappropriate patient treatment administered.The patient demographics were requested and not provided.There is no patient injury.
Additional Manufacturer Narrative
The device has arrived for product evaluation.The reported failure of inaccurate values was not confirmed.The suspect clearsight module was connected to a known working hemosphere system for testing three times and each time there were no error messages observed.There were normal blood pressure readings and a normal waveform that displayed.The system was left to run for one hour with no issues present.A visual inspection found no damage to the module.There was no defect found.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the issue.Based on the available information, there is no evidence that supports or confirms the failure mode is associated with a manufacturing or design defect.It is not known if 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 the monthly review.The device history record review was completed and all manufacturing inspections passed with no non-conformances.

• Brand Name: HEMOSPHERE
• Common Device Name: CLEARSIGHT MODULE
• 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: 21260829
• Report Number: 2015691-2025-00546
• Device Sequence Number: 9475432
• Product Code: DQK
• UDI-Device Identifier: 00690103202762
• UDI-Public: (01)00690103202762(11)211110
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K201446
• 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
• 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 Model Number: HEMCSM10
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2021
• 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