MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT; HEMOSPHERE MONITOR

Model Number HEM1

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

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

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned as the serial number of the device is unknown, the exact device involved cannot be determined.As the serial number is unknown, the udi information is unknown.The device history record review cannot be completed as the serial number is unknown.The diagnostic logs have been requested.A supplemental report will be submitted if there is any information from the logs that is able to be provided.

Event Description

It was reported that there were inaccurate low ci values when using the hemosphere instrument, hem1.The patient was a healthy non-cardiac surgical patient with no cardiac history.The blood pressure was in the 130 systolic.The patient was not treated on the inaccurate values.The patient demographics are not available.This was during patient use.There is no patient injury.

Manufacturer Narrative

The diagnostic logs were returned for review.The data analyzed shows no indication of inaccurate co ci measurements.The issue appears to be the clinician's inexperience with the hsni system.The hsni and ev1000 systems use slightly different co algorithms.The data determined that the patient exhibited symptoms of a hypovolemic condition in which the co and ci must be low.Low ci was confirmed through the clinical data analysis.The raw arterial pressure waveforms from the patient was reprocessed through the algorithm for the ev1000 monitor.The resulting co ci data was compared to the co ci data from the hem1 monitor.Both data sets showed similar low ci measurements, well below 2.0 l min m2.The data from the hem1 device is consistent with the ev1000 device.The assignable cause of the issue is design.The issue could not be confirmed.There was no defect identified during the investigation.A risk assessment and corrective action were initiated for this issue.

Manufacturer Narrative

Correction update, after additional review, the data logs appeared to correlate to the reported event description; however, the edwards rep could not confirm the date.Additionally, the edwards rep did recall that the issue occurred on either (b)(6) 2021 or (b)(6) 2021 , which is a correction from the originally reported date of (b)(6) 2021 log files were reviewed.

• Brand Name: HEMOSPHERE INSTRUMENT
• Type of Device: HEMOSPHERE MONITOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; one edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 12502689
• MDR Text Key: 272501118
• Report Number: 2015691-2021-05272
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2021

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 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
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 11/22/2021; 11/18/2021
• Supplement Dates FDA Received: 11/23/2021; 12/10/2021
• 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
• Type of Device Usage: Reuse
• Patient Sequence Number: 1