MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMCSM10; HEMOSPHERE 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 11/17/2023

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 completed and all inspections passed with no non-comformances.

Event Description

It was reported that the hemcsm10 acumen cuff read 15 to 20 points lower than systolic and diastolic blood pressures from the arterial line and brachial line.Troubleshooting included trying different cuffs and fingers.There were no adverse events but the acumen cuff was on the opposite side of the art line.This was during use.There is no patient injury.Patient demographics were unavailable.

Manufacturer Narrative

A supplemental mdr is being submitted due to product evaluation findings.Sections g6, h2, h6: type of investigation, investigation findings, and investigation conclusions have been updated.One hemcsm10 was received for product evaluation.The suspect hemcsm10 was connected to a known working hem1 hot mock-up system.The hemcsm10 caused no errors.It was also able to obtain normal blood pressure readings and waveform.The hemcsm10 was ran for 1 hour and the readings remained stable.No damage was found.There was no defect.

• Brand Name: HEMCSM10
• Type of Device: HEMOSPHERE 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 richards ; one edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18271727
• MDR Text Key: 329775073
• Report Number: 2015691-2023-18118
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203687
• 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: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• 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: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2023
• 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