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 02/08/2023

Event Type  malfunction  

Manufacturer Narrative

The hemosphere unit has been requested to be returned for evaluation; however, it has not arrived.Once it has arrived and the evaluation completed a supplemental submission will be sent with the evaluation findings.The device history record review has been completed and all manufacturing inspections passed with no non conformances.

Event Description

It was reported that there was a malfunction with the hemosphere instrument during patient monitoring.The heart rate signal on the hemosphere was higher than it was shown on the bedside patient monitor, per the clinicians.The reading displayed as 190 beats per minute.The actual heart rate was 65 beats per minute.When they exchanged for a different hemosphere unit, then it resolved the issue.The sync cable that sends the heart rate reading to the bedside patient monitor was exchanged for another one, but that did not resolve it.Per the edwards representative, it is unknown if there were any fault or alert messages displayed.There was no inappropriate patient treatment administered.The patient demographics have been requested, but were not received, information is unknown.There was no patient harm or injury.

Manufacturer Narrative

The hemosphere instrument hem1 was received and evaluated.The unit was connected to known working components, clearsight module, pressure controller, heart reference sensor and a patient simulator for testing.There was no failure found.A reading of mmhg was 120 over 80, plus or minus 3.The blood pressure measurement was displayed at 80.The components were left to run for one hour with no difference in heart rate.There were no error messages that displayed.A visual inspection was performed and there was no physical damage found.The reported failure was not confirmed.

• 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: 16432340
• MDR Text Key: 310182754
• Report Number: 2015691-2023-11033
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)211018
• 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
• Report Date: 04/27/2023

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 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: 02/08/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 04/25/2023
• Supplement Dates FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• 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