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

Model Number HEM1

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

The hem1 instrument will not be returned for evaluation.This was determined to be a software/algorithm issue at the facility by an edwards lifesciences r&d engineer.The diagnostic logs are being reviewed, and when the findings are available a supplemental report will be submitted.The device history record review was completed, and all manufacturing inspections passed with no non-conformances.The udi information is (b)(4).

Event Description

It was reported that the hem1 instrument was being used for patient monitoring when the clinician noted that the right ventricular ejection fraction display was lower than expected for the patient's condition.Troubleshooting was performed in the operating room during the procedure.All connections were checked, and there was no issue found.The ecg cable was checked visually to ensure no damage, or any mechanical issues, and there was none.The cable was disconnected from the hem1 to remove the heart rate value that was displayed, and then the value was resumed displaying when the cable was re-connected.The value displaying was as expected.The anesthesiologist noted that the patient's left ventricular ejection fraction was between 55-60%, prior to surgery.Then looking at the patient's cardiac output and stroke volume, they expected the right ventricular ejection fraction to be higher than the 25-30% that was currently displaying.The heart rate displayed on the hem1 screen was 98 bpm, and that matched the hr display on the spacelabs exactly, for several minutes.The heart rate continued to match after the hr analog input cable to the hem1 was disconnected and re-connected.As the cco calculation was accurate, the 70cc2 cables, and the sg module were working appropriately.Since both co and hr values are matching values expected by the clinician for the patient, the issue is not a hardware failure.It was determined to be a system, software and algorithm issue.There was no patient injury reported.There was no inappropriate patient treatment reported.The anesthesiologist noted that this had occurred with other patients with similar left ventricular ejection fraction readings.Another mdr report will be sent for the other event.The submission number will be provided in a supplemental report.

Manufacturer Narrative

The hem1 instrument will not be returned for evaluation.This was determined to be a software/algorithm issue at the facility by an edwards lifesciences r&d engineer.The diagnostic log review is pending and when the findings are available a supplemental report will be submitted.The other event involved with this hem1 was reported under 2015691-2020-13950.

Manufacturer Narrative

The hem1 unit was not returned for evaluation.The diagnostic log data was analyzed by edwards engineers.The rvef, cardiac output and heart rate parameters were reviewed.The co and hr readings were within normal ranges.The rvef did appear to be at the low end.The data was analyzed to confirm whether the algorithm on the monitor behaved as expected.From the analysis it was determined that the algorithm did behave as intended.The calculation of the rvef parameter, based on the measurements taken from the swan-ganz catheter, is functioning as we would expect.There is no evidence to indicate that the rvef value is correct or incorrect, only that the monitor, based on the logs, is behaving as intended.There is also no evidence that the catheter or the monitor is physically behaving correctly or incorrectly, based on the logs they appear to be working as expected.No further action will be taken.

• Brand Name: HEMOSPHERE INSTRUMENT MONITOR
• Type of Device: HEMOSPHERE MONITOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10674225
• MDR Text Key: 211266192
• Report Number: 2015691-2020-13949
• 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: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• 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: 10/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 70CC2 CABLES, SG MODULE