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

Model Number HEM1

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Event Description

It was reported that, due to use error with this hemosphere monitor, there was a delay in treatment with providing the patient a blood transfusion.The customer mistakenly thought that the patient data was overwritten when the recall oximetry data was performed, when only the oximetry calibration data is overwritten, not the patient data.Generic patient data was entered into the hemosphere monitor once the patient was moved to the icu.The cardiac index (ci) and stroke volume index (svi) parameters were measured using the generic data, which were then inaccurate.This is intended behavior and not a malfunction of the device.The inaccurate ci and svi measurements issue occurred due to customer use error and because the sales representative also misrepresented the correct use of the device.The customer performed the blood transfusion while noticing the ci and svi values they monitored were wrong, as the value should have been lower.Although no unnecessary treatments were performed, the necessary blood transfusion was delayed.There was no patient injury due to the delay of the transfusion.

Manufacturer Narrative

The hemosphere monitor will not be returned for evaluation.This is considered as an isolated issue, but edwards marketing team is planning a training for all sales representatives.On june 27, 2022, the sales representative visited the site explaining the correct use of the device and providing a customer letter.On july 01, 2022, an awareness communication was provided to all sales personnel from the safety management manager.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.Device not returned.

• 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: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 15000556
• MDR Text Key: 301588496
• Report Number: 2015691-2022-06740
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K213682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HEM1
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2022
• 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 Outcome(s): Hospitalization