MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT MONITOR

Model Number HEM1

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

The product has been requested to be returned but has not yet arrived.When the product evaluation results are available a supplemental report will be submitted.The serial number of the device is unknown.When the serial number is available, the device history record review will be completed and the results will be submitted in a supplemental report.

Event Description

It was reported that the hemosphere instrument, hem1 monitor, was being used during patient monitoring when the sv values were found to not be working.The cables used were exchanged and that did not help.They secured all connections, but that still did not resolve the issue.There was a balloon pump being used and the clinician stated that when it is used this "affects the numbers".It is unknown how the numbers are affected.The facility has been contacted several times and has been asked for additional details, but there has been no response.The clinicians have said that the co and ci and heart rate numbers were within acceptable range.The facility has since been given instructions on how to set up the equipment and instructed on which cable should be inserted into which port.There was no inappropriate patient treatment administered.The patient demographics were not provided.There is no patient harm or injury.

Manufacturer Narrative

This is a correction to note that upon further information obtained about this event, the complaint is no longer reportable.An edwards engineer spoke with a clinician at the hospital.Upon gathering further information it was found that the clinician did not understand the heart rate output he could receive given the way the hemosphere system was set up.The edwards engineer gave further instructions on set up of the system given the clinician's expectations.There was no malfunction of the hemosphere system and no harm or injury to the patient.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: HEMOSPHERE INSTRUMENT MONITOR
• Type of Device: HEMOSPHERE INSTRUMENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10326473
• MDR Text Key: 201197681
• Report Number: 2015691-2020-12667
• 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,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• 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
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1