MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMCSM10; 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 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

The product has not been returned for evaluation.When it arrives and the product evaluation has been completed, a supplemental report will be submitted.The device history record review was not completed as there was no serial number provided.

Event Description

It was reported that the hemcsm10 generated inaccurate values.This was with a (b)(6) patient with good peripheral flow.The patient was in the interventional radiology ir for a neuro embolization.Clearsight was reading full signal bars and had an uninterrupted waveform.The ci was 0.9 and sv was 28.The physician mentioned that if the numbers were correct the patient should be already coding.The patient had no indicators of being in heart failure i.E.Low end of normal bp normal hr physical exam oxygen levels etc.The physician did not act on the numbers because he did not believe them.The rep tried switching the finger changed the cuff size from medium to large and tried unplugging and replugging the cable but was unsuccessful.This was during use.There was no inappropriate treatment administered.

Manufacturer Narrative

The product was not returned for evaluation.The logs that had been sent in were corrupted and the data was unable to be read.

Manufacturer Narrative

Logs were analyzed and appear to correlate to the reported event; however, the date of the data and the reported date of the event do not match.The correct date is unable to be confirmed, as the reporting rep no longer works for ew.H3 other text : product not returned.

• Brand Name: HEMCSM10
• 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: 12351492
• MDR Text Key: 267698187
• Report Number: 2015691-2021-04809
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142749
• 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,Followup
• Report Date: 01/09/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/20/2021
• Supplement Dates Manufacturer Received: 09/09/2021; 12/10/2021
• Supplement Dates FDA Received: 09/22/2021; 01/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 95 YR