MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT MONITOR

Model Number HEM1

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for analysis; however, it has not yet been received.Upon return of the product a supplemental report will be submitted with the evaluation findings.The device service history record review has not been completed.When the results are available a supplemental report will be submitted.

Event Description

It was reported that the hemosphere hem1 monitor froze during patient monitoring.They obtained readings at 8 pm, then at 9 pm they discovered the screen had frozen.The cco readings froze on the display screen and would not provide any readings.The clinicians rebooted and re-started the cco readings; however, it froze again.They exchanged the suspect hem1 monitor for a different unit and then the monitoring continued without any further issue.There was no inappropriate patient treatment administered.There was no harm or patient compromise.Patient demographics not available.

Manufacturer Narrative

One hemosphere monitor was returned for product evaluation.The hemosphere monitor and the swan ganz module were left to run for over an hour and there were no errors that were identified.The display screen did not freeze.There were appropriate values that were provided.The diagnostic logs were reviewed and there were swan ganz fault messages that displayed during the event regarding the cardiac output and blood temperature being ¿out of range.¿ further inspection of the log files found that the end user pulled the catheter/blood temperature connector from the hemosphere monitor.This caused the monitoring of the continuous cardiac output to stop.It was re-connected but it was not re-started for that day.There was no defect found.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The reported event was not confirmed by evaluation.There was no inappropriate patient treatment administered.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.Per the log files, it was discovered that the clinician did not restart the continuous output after plugging it back into the connector.Therefore, user factors contributed to the stated event, not a product malfunction.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 a part of the monthly review.The udi information is (b)(4).Refer to submission 2015691-2018-00016 for the swan ganz module.

• Brand Name: HEMOSPHERE INSTRUMENT MONITOR
• Type of Device: HEMOSPHERE INSTRUMENT 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: lynn selawski ; one edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 7129253
• MDR Text Key: 95754001
• Report Number: 2015691-2017-04365
• Device Sequence Number: 1
• Product Code: DQK
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

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: 02/07/2022
• Device Model Number: HEM1
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 01/25/2018
• Supplement Dates FDA Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2017
• 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