MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE ADVANCED MONITOR; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number HEM1

Device Problem Incorrect Measurement (1383)

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

Event Date 05/30/2023

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

As reported, during use in patient with this hemosphere monitor, there were discrepancies between the stroke volume value displayed (40ml), the clinical assessment of the patient and the image in the ultrasound of the heart.The hemodynamic parameters displayed were as normal, which was not confirmed by the observed actual state of the patient.The expected value according to the patient status was 20ml.Customer would like to be retrained.Patient demographics unable to be obtained.No error message was displayed.There was no allegation of patient injury.The device was not available for evaluation.

Manufacturer Narrative

Added information to section d4 (expiration date) and h4 (device manufacturer date), h6 (type of investigation).Updated sections d9 (device availability), h3 (device evaluated), h6 (component code), h6 (investigation findings) and h6 (investigations conclusion).No product was returned for evaluation since customer refused.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.

• Brand Name: HEMOSPHERE ADVANCED MONITOR
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 17180281
• MDR Text Key: 317638522
• Report Number: 2015691-2023-14115
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

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: HEM1
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1