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	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is anticipated to be returned for evaluation but has not yet been received.A supplemental report will be forthcoming when the investigation is completed.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.
Event or Problem Description
It was reported that the hemcsm10 was providing information that was not consistent with another hemcsm10 that was tested using the same monitor.The rep could not recall if any alarms or errors displayed.The customer did not accept the displayed information and requested the rep assess the technology as it was too low for patient conditions nor correlated with nibp wnl.There were no signs of physical damage or poor module seating in hem1.This was during use.There was no patient injury.No patient demographics were obtained.
Additional Manufacturer Narrative
The hemosphere clearsight module hemcsm10 was returned for evaluation.The hemcsm10 was connected to a known working hem1 hot mock-up system.Normal values were obtained with normal blood pressure readings and waveform.The device was monitored for over an hour and the values remained steady.No damage was found.No inaccurate values appeared, there was continuous blood pressure, and there were no pressure or cuff errors during evaluation of this device.The reported condition could not be confirmed; therefore, no product or process malfunction was identified.A root cause could not be established.The operator's manual and ifus include states do not apply finger cuffs on thumb or previously fractured fingers and improper finger cuff placement can lead to inaccurate monitoring.It goes on to instruct the user to apply the cuff on the middle, ring or index finger.

• 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: erika bonilla ; one edwards way; irvine, CA 92614
• MDR Report Key: 21114175
• Report Number: 2015691-2025-00184
• Device Sequence Number: 12682611
• Product Code: DQK
• UDI-Device Identifier: 00690103202762
• UDI-Public: (01)00690103202762(11)230112
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203687
• 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): 03/14/2025

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
• Device Lot Number: 16804660
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• 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