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 12/15/2021

Event Type  malfunction  

Event Description

It was reported that the mean arterial pressure values that displayed were significantly higher on the hem1 instrument than were displayed on the philips bedside monitor.The exact numbers displayed are unknown.There were no error messages noted.They exchanged the analog cable and the iabp module, but it did not resolve the issue.They checked to make sure the settings on the hem1 were correct and they still received the same issue.When they exchanged the hem1 instrument for another one, then the issue was resolved.This occurred during patient use.There was no inappropriate patient treatment administered.The patient demographics information was requested and is not available.There was no patient harm or injury.

Manufacturer Narrative

The suspect hem1 unit is in route for evaluation, but has not yet arrived.Once the product evaluation has been completed the findings will be submitted in a supplemental report.The device history record review was completed and all manufacturing inspections passed with no non conformances.The udi number is (b)(4).

Manufacturer Narrative

The hemosphere hem1 monitor was returned for product evaluation.A visual inspection found no physical damage.The hem1 was connected to a known working swan ganz module and hemosphere oximetry cable for testing.The system verification test was performed on both module and smart cable ports on the hem1.The co and sv02 values remained within appropriate parameters.There were no error messages observed.Using the hemosphere analog input cvp check procedure both analog port 1 and analog port 2 were tested and both displayed cvp and map readings.All readings were 8 mmhg lower than expected.A known good working backplane component was installed in the suspect hem1.Testing was completed again and the readings were now as expected.The issue was confirmed by evaluation.It was determined the root cause was a defective backplane component.

• 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: 13048955
• MDR Text Key: 283236706
• Report Number: 2015691-2021-06953
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)170803
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

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 Expiration Date: 08/03/2022
• 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: 12/15/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 03/15/2022
• Supplement Dates FDA Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2017
• 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: PHILIPS MONITOR IABP MODULE ANALOG CABLE