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

Model Number HEM1

Device Problem Incorrect Measurement (1383)

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

Event Date 12/19/2022

Event Type  malfunction  

Event Description

As reported, during use in patient of this hemosphere monitor, svri displayed was four times lower than svri stated on the phillips monitor.Svri displayed on the hemosphere was 500 mmhg while in phillips monitor svri displayed was 2000mmhg.Rest of parameters showed in both monitors matched and were correct.Different cables and a different hemosphere monitor were used but the issue remained.Also placement of the modules was checked and various tests performed with a fluke tester confirmed that voltage in hemosphere and philips analog ports were correct.There was no allegation of patient injury.Patient demographics unable to be obtained.

Manufacturer Narrative

Follow up is ongoing to clarify whether the device is available for evaluation.An investigation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results.

Event Description

As reported, during use in patient of this hemosphere monitor, systemic vascular resistance index (svri) displayed was four times lower (500 mmhg); than svri stated on the phillips monitor (2000mmhg).Values were confirmed to be incorrect by manually calculation.Mean arterial pressure (map) (92 mmhg) and central venous pressure (cvp) (40mmhg) received through analog cable from the philips monitor were not correct.Swan seems to be correct since cardiac output (co) value was ok.There were no error messages displayed.Hemosphere monitor was replaced for a new one (medwatch #26525) but the issue remained.Also placement of the modules was checked and various tests performed with a fluke tester confirmed that voltage in hemosphere and philips analog ports were correct.As per customer opinion, the issue could also be related to the philips monitor.In this case the patient was treated incorrectly with noradrenaline even if finally there was no patient injury.Patient demographics unable to be obtained.The device was available for evaluation.

Manufacturer Narrative

Updated: b5 (description); d4( lot number and expiration date) d9 (device availability); section e(initial reporter), h3 (device evaluated by manufacturer), h4 (device manufacturer date) the hemosphere monitor was sent to our technical service center for a full evaluation.Complaint was unable to be confirmed.From visual inspection, no defects were identified on this hemosphere monitor.As received, the monitor was connected to a workshops power supply and digital multimeter to simulate slaved map and cvp values.Map and cvp values were simulated and they were all within range.The set up was changed for different full scales and different voltage ranges and obtained values were within range.Values were simulated for both analog ports without any issue.Since svr and svri are calculated based on the co , co values were simulated by using customers sgm and a workshops cco simulator and they were also within range.Monitor was run in our functional tester, and it successfully passed the test.Since it was reported the issue occurred randomly at separate dates (past event registered in medwatch # 25802), the backplane and analog pcba have been replaced in order to prevent any possible issue from the hemospheres side.After this, device passed electrical safety test, functional test and final verification.The source of the failure could not be identified as no defect was found.The map and cvp analog inputs take in a standard dc input voltage from patient monitors with invasive pressure modules equipped with compatible dc analog output voltage ports.Patient monitors, depending on the model, have different specifications on how the output voltage ports are scaled to the measured pressure.Therefore, the hemosphere must be properly configured to the connected patient monitor specifications in order to function properly.This functionality can be readily confirmed by inputting a known pressure into the patient monitor and confirming that the pressure measured by the patient monitor is the same as that displayed on hemosphere.A range of pressures throughout the physiological range should be checked for each invasive pressure module on the patient monitor.The patient monitor, the hemosphere, and the analog slave cables connecting the patient monitor to the hemosphere must be functioning properly to ensure accurate readings.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met and inspections passed successfully.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: HEMOSPHERE ADVANCED MONITOR
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 16156987
• MDR Text Key: 308745822
• Report Number: 2015691-2023-10146
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2020
• 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