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 02/09/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was a malfunction with the clearsight module.The edwards representative states as he was using his demo clearsight module at his residence and self-testing the equipment to ensure it was in working order.The clearsight module was giving inconsistent blood pressure readings.The readings were displaying erratically, going up and down.The reading was 150s systolic.The reading was expected to be 110-120 systolic.The issue was isolated to the clearsight module.When he received a replacement clearsight module it worked on his monitor with no issues.There was no apparent damage seen.Before patient use.There was no patient involvement.

Manufacturer Narrative

The clearsight module was received and evaluated.The suspect device was connected to known good working components for testing.Monitoring started and after fifteen minutes there was a message of hemosphere module fault error that displayed.The patient values were steadily displayed until the error occurred, then the connection was lost.When the suspect device was reconnected there was a fault of l-tech module slot - communication error that displayed.A known good working printed circuit board assembly was installed and removal of the suspect one was completed.With the known working pcba, monitoring continued for one hour and there were no errors that occurred.The technician re-installed the original suspect pcba and then an error occurred after 25 minutes of monitoring.A visual inspection was performed and there was no physical damage found.The root cause was found to be the printed circuit board assembly component.An investigation has been initiated to consider potential operational component issues.

• Brand Name: CLEARSIGHT MODULE
• Type of Device: 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: jessica atallah ; one edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 16432372
• MDR Text Key: 310193097
• Report Number: 2015691-2023-11034
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00690103202762
• UDI-Public: (01)00690103202762(11)210323
• 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: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

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 Operator: Health Professional
• Device Model Number: HEMCSM10
• Device Catalogue 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
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 04/16/2023
• Supplement Dates FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2021
• 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