MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT

Model Number HEM1

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

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

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

The product is not expected to be returned.The diagnostic log data is expected to be returned for review.When the results are available a supplemental report will be submitted.The device history record review could not be completed as the serial number to identify the unit is unknown.The udi number is unable to be located as the serial number is unknown.The medwatch submission numbers for the other products involved will be provided in a supplemental report when available.Current literature states that there is only modest that the fick calculation is not the standard of care for estimating accurate co/ci values.There is only modest agreement between thermodilution and fick calculation estimates.Thermodilution calculation better predicts patient status and should be used over fick in clinical practice.It is unknown if procedural or patient factors played a role in this event.

Event Description

It was reported that there were inaccurate values with the hemosphere instrument.The post-op heart surgery patient was being monitored with a hem1 and swan ganz catheter.The customer states the cardiac output values were frequently running half of the calculated fick values.It would take several hours for the hemosphere and swan values to align/correlate with calculated fick values.This occurred with two hem1 units that had been recently upgraded to be able to run flotrac.The sg catheter was switched from an upgraded hem1 to a second recently upgraded hem1 and to a third hem1 unit.All values were running with close correlation, but the co values were still up to 1l from the calculated fick value and the ci was still off by 0.5.This submission represents the third hem1 involved.There was no patient harm or injury.There was no inappropriate patient treatment administered.

Manufacturer Narrative

The product was not returned for evaluation as the serial number of the unit could not be identified.Diagnostic log data was returned and reviewed for the issue and there was no malfunction identified during the event.The submission numbers for the other products involved in this event are: 2015691-2021-04532, 2015691-2021-04536, 2015691-2021-04528, 2015691-2021-04497.

• Brand Name: HEMOSPHERE INSTRUMENT
• Type of Device: HEMOSPHERE INSTRUMENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 12290057
• MDR Text Key: 265568800
• Report Number: 2015691-2021-04537
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K163381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SG CATHETER
• Patient Age: 57 YR
• Patient Weight: 77