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

Model Number HEM1

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2020

Event Type  malfunction  

Manufacturer Narrative

The product has not arrived for evaluation.Once it has been received and the evaluation completed a supplemental report will be submitted with the evaluation findings.The device history record review is pending.Once the results are available they will be submitted in a supplemental report.The udi information is (b)(4).

Event Description

It was reported that during patient monitoring with the hemosphere instrument (hem1) in use, there was a difference in the blood pressure readings between the hem1 and the bedside monitor.The smart pressure cable was moved from port 1 to port 2 on the hem1 and then issue was resolved and the readings correlated.The issue was isolated to port 1 on the hem1.There were no error messages displayed.The waveform was not abnormal.The patient demographic information was requested; however, the hospital will not release it.There was no inappropriate treatment administered.There was no patient harm or injury.

Manufacturer Narrative

The device history record review was completed and all manufacturing inspections passed with no non-conformances.The record of servicing has been reviewed and there is no previous related record.Attempts are being made for product return of the hem1 and the unit has not been received.Once it arrives and an evaluation has been completed the findings will be submitted in a supplemental submission.

Manufacturer Narrative

One hemosphere instrument, hem1, was received for evaluation.The unit was tested per the system level verification test with a known good working pressure cable and pressure simulator.Both cable ports were tested and both ports were found to be functioning normally.There were no abnormalities observed.The diagnostic logs were reviewed and there was a fault message of "co-arterial waveform compromised" that was displayed during the timeline of the event.Analyzing the log data, the pressure cable was first used on port 1 and it was observed that an attempt to zero the pressure cable at 5am on oct 31 was performed.The pressure cable was exchanged from port 1 to port 2 around 6:27am.While the ew representative's photos showed the monitor¿s readings aligned with the data in the diagnostic logs, the port change timing did not align.The picture shows the supposed port 2 readings at 6:18 am on oct.31, but the diagnostic logs show the port was switched at 6:27 am.In analyzing the readings in the minutes before and after the port change, the data did not suggest a shift in the trends between the 2 ports.Additionally, the system level verification test that was performed was found that the unit was functioning normally.The reported event could not be confirmed.There is no evidence or indication that a manufacturing defect is responsible for the reported issue; therefore, no corrective action was taken.No further actions will be taken at this time.With any hemodynamic monitoring readings can change quickly and dramatically.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make decisions.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.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 the monthly review.

Manufacturer Narrative

Additional information regarding further evaluation of the hemosphere monitor.A known good working sg module and oximetry cable were connected to the suspect hem1 monitor for testing.The system verification test was performed on both module and smart cable ports.The co and sv02 values remained within appropriate patient parameters.There were no error messages noted.The test was also run with a known working pressure cable on both smart cable ports.They were left to run for 2 hours each.Still all values remained with appropriate parameters with no error messages displayed.There was no defect found.

• Brand Name: HEMOSPHERE INSTRUMENT
• Type of Device: HEMOSPHERE INSTRUMENT/MONITOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10863842
• MDR Text Key: 220978517
• Report Number: 2015691-2020-14482
• 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,Followup
• Report Date: 11/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMART PRESSURE CABLE, BEDSIDE MONITOR.