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 07/12/2021

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 was completed and all manufacturing inspections passed with no non-conformance's.The medwatch submission numbers for the other products involved will be provided in a supplemental report when available.

Event Description

It was reported that there were inaccurate values with the hemosphere instrument.This was while using the flotrac and hemosphere technology.The cardiac output values were 18l/min, the cardiac index values were up to 9, stroke volume was up to 180's plus.This was while monitoring an ecmo patient.When they switched to a different hemosphere the values stayed the same.When they switched to an ev1000 monitoring system they still received the same result.There were no alerts or alarms.There was no inappropriate patient treatment administered.There was no patient harm or injury.Patient demographic information was requested, but is not available.

Manufacturer Narrative

The product will not be returned for evaluation.The diagnostic logs data was returned and reviewed.From the data it was determined that there was no defect found with the product.The reported issue could not be confirmed.The submission numbers for the other products involved in this event are; 2015691-2021-04531, 2015691-2021-04524, 2015691-2021-04526, 2015691-2021-04451.

• Brand Name: HEMOSPHERE INSTRUMENT
• Type of Device: HEMOSPHERE INSTRUMENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 12289680
• MDR Text Key: 265469083
• Report Number: 2015691-2021-04531
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)180616
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2023
• Device Model Number: HEM1
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 07/30/2021
• Supplement Dates FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLOTRAC DEVICE, SG CATHETER, EV1000 SYSTEM; FLOTRAC DEVICE, SG CATHETER, EV1000 SYSTEM