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  

Manufacturer Narrative

The device has been requested for return but has not yet arrived.When it has arrived and the product evaluation has been completed, the evaluation findings will be sent in a supplemental report.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, during patient use.There were inaccurate blood pressure readings that occurred.The readings were approximately cs bp 160s/30s, the nibp 200s/100s there were no error messages that displayed.The issue was isolated to the csm.There was no arterial line.There was no inappropriate patient treatment administered.There was no patient harm or injury.The patient demographics are not available.

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 (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; one edwards way; irvine, CA 92614
• MDR Report Key: 18222573
• MDR Text Key: 329441432
• Report Number: 2015691-2023-17758
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2023
• 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