MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT MODULE

Model Number HEMCSM10

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2023

Event Type  malfunction  

Event Description

It was reported that there was a malfunction with the clearsight module, during patient use.There were inaccurate values that displayed.The nibp was in the 200s.The femoral line was in the 180s.The clearsight reading was in the 90s.The malfunction was isolated to the clearsight module.There were no error messages.The clinicians used the femoral line value for treatment.Sqi was 3 to 4 bars.There was no inappropriate treatment administered.Patient demographics unknown.There was no patient harm or injury.

Manufacturer Narrative

The device has been requested for return but has not yet arrived.Once it arrives and the product evaluation has been completed the evaluation findings will be submitted in a supplemental report.The device history record review has been completed and all manufacturing inspections passed with no non conformances.

Manufacturer Narrative

The clearsight module was returned and evaluated.The suspect csm was connected to a known good working hemosphere instrument for testing.There were no error messages that displayed.There were normal blood pressure readings and a normal waveform that were able to be acquired.The components were left to monitor for 1.5 hours.The readings remained stable.There was no issue found.A visual inspection found no damage to the device.The reported issue was not confirmed.There will be no further action taken at this time.

• Brand Name: CLEARSIGHT MODULE
• Type of Device: CLEARSIGHT MODULE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; one edwards way; irvine, CA 92614
• MDR Report Key: 18222559
• MDR Text Key: 329172534
• Report Number: 2015691-2023-17756
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00690103202762
• UDI-Public: (01)00690103202762(11)220608
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1