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	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a malfunction with the clearsight module, during patient use.There was an inconsistency with the blood pressure readings.They were not correlating with the patient's condition.The numbers received and what they were expected to be were requested and not provided.They attempted troubleshooting, but were unable to correct the issue.There is no patient injury.There was no report of inappropriate patient treatment.The patient demographics were requested and not provided.The device has been requested to be returned for evaluation, but has not yet arrived.The device history record review has been completed and all inspections passed with no non-conformances.A supplemental report will be submitted with the product evaluation results when available.
Additional Manufacturer Narrative
The clearsight module was returned for evaluation.It was connected to a known good working hemosphere system and cuff simulator for testing.The values that displayed were within appropriate parameters plus or minus 5mmhg.The system was left to run for over an hour.There were no inaccurate values that occurred.The reported issue was not confirmed.An engineering evaluation has been initiated to assess for any manufacturing related processes which could be correlated to the issue.Once the results are available a supplemental submission will be sent.
Additional Manufacturer Narrative
The engineering evaluation has been completed.The issue could not be confirmed or replicated during analysis; the device responded appropriately during testing.It is not known if any procedural factors may have contributed to the event.There was no evidence of a manufacturing nonconformance.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 CLEARSIGHT MODULE
• 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: 19326177
• Report Number: 2015691-2024-03613
• Device Sequence Number: 12392101
• Product Code: DQK
• UDI-Device Identifier: 00690103202762
• UDI-Public: (01)00690103202762(11)230601
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2024

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 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: 04/23/2024
• Supplement Date Received by Manufacturer: 06/10/2024; 07/19/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 07/02/2024; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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