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

Model Number HEM1

Device Problem Incorrect Measurement (1383)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

The customer would not return the device as it was indicated that the device was functional.The data logs were provided for review and the results of investigation will be provided through a supplemental report.

Event Description

As reported, after performing the oximetry svo2 (mixed venous oxygen saturation) /scvo2 (central venous oxygen saturation) calibration using millimoles per liter (mmol/l) instead of grams per deciliter (g/dl) as unit of measurement by mistake, the hemosphere monitor displayed lower svo2 value than expected if the desired unit of measurement had been selected.There was no additional information regarding the svo2 values provided.Patient was treated with noradrenaline, propofol and fentanyl but it is not known if the medication treatment was in response to the decreased oxygenation values.The issue was noticed 6 hours later, when the svo2 was recalibrated.It had not been noticed before because even though the unit of measurement used was not the desired one by the user, the predefined value range was still in the green zone.In this case, there were no serious consequences for the patient, a part from staying longer in the icu due to this incident.The monitor was not available for evaluation, since this was not a product malfunction.Diagnostic logs were provided for analysis.

Manufacturer Narrative

It was further specified that patient was treated with ringer's lactate 500ml to get more volume and there was a delay in extubating due to this incident.A training will be scheduled on edwards products, the customer will be informed and trained on the correct process steps to choose the correct unit of measurement used during calibration.The diagnostic log was reviewed and there was no defect was found.Hence, the report of inaccurate hemodynamic parameters could not be confirmed.The device service history record review was completed, and all manufacturing inspections passed with no non-conformances.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.

• Brand Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Type of Device: HEMOSPHERE ADVANCED MONITOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 12252150
• MDR Text Key: 264281249
• Report Number: 2015691-2021-04400
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K211465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2022
• Device Model Number: HEM1
• Device Catalogue Number: HEM1
• Device Lot Number: 13800150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2021
• Initial Date FDA Received: 07/30/2021
• Supplement Dates Manufacturer Received: 08/12/2021
• Supplement Dates FDA Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 73 YR