MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT

Model Number HEM1

Device Problems Appropriate Term/Code Not Available (3191); Unintended Electrical Shock (4018)

Patient Problems Shock (2072); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2022

Event Type  malfunction  

Manufacturer Narrative

Product has been requested and has not yet been received.Once received and evaluated, the evaluation findings will be sent under a separate submission.Submission references linking the three events; 2015691-2022-05861, 2015691-2022-05862.

Event Description

It was reported that there was an electrical shock to the patient's finger during patient monitoring with the hemosphere.The patient was being monitored with a finger cuff and experienced an electrical shock on their finger when the clinician started using the bovie.At the same time it was noticed that there was waveform interference with the drager monitor, it displayed squiggly lines up and down.When the patient mentioned the shock, the monitoring session was paused, but the shock continued.Once the finger cuff was disconnected, the shock was resolved.The acumen iq cuff was connected to a hemosphere monitor with the latest software version.An electrician was asked to investigate and the findings were that the outlets that the hem1 was connected to were not properly grounded and there was a high amount of voltage in the room.The equipment was repositioned and the grounding was checked once the patient left the room.The bovie was connected to a surge protector.The electrical shock occurred in room c two times and once in room d.The biomed and hospital electrical team checked the room after the second incident.The hospital team noted that there was a higher than normal amp flow in the room.The hospital electrical engineer team resolved a grounding issue after the incident.It is unknown if the patient was wearing jewelry or touching metal when bovie was used.The patient experienced pain, but there was no patient injury.There was no inappropriate patient treatment administered.This report represents the second incident.

Manufacturer Narrative

The hem1 instrument is expected to be returned but has not yet arrived for evaluation.Once received it will be evaluated and the findings submitted in a supplemental report.The device service history record review has been completed and all manufacturing inspections passed with no non-conformances.The submission numbers for the other 2 incidents will be provided once available.

Manufacturer Narrative

The suspect hemosphere hem1 unit was returned for product evaluation.The unit was connected to a known working swan ganz module and oximetry cable for testing.The system verification test was performed on both module and smart cable ports.The cardiac output and sv02 values were within appropriate parameters.There were no error messages that displayed.The suspect hem1 was connected to a known working clearsight module, pressure controller, heart reference sensor and patient simulator for further testing.The reading received was 120 80, plus or minus 3.There were no error messages displayed.A known good working finger cuff was connected to the technician with the other components and there was no electrical shock felt.Nor were there any squiggly lines displayed on the screen.The hemosphere functioned normally.There was physical damage noted to the rear enclosure heat staking.The issue was not confirmed.

• Brand Name: HEMOSPHERE INSTRUMENT
• Type of Device: HEMOSPHERE INSTRUMENT
• 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: 14490598
• MDR Text Key: 293084571
• Report Number: 2015691-2022-05863
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)190830
• 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: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2019
• 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
• Treatment: BOVIE, FINGER CUFF, DRAGER MONITOR
• Patient Outcome(s): Other
• Patient Sex: Female