MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT MONITOR

Model Number HEM1

Device Problems Incorrect Measurement (1383); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

The hem1 monitor has been received for evaluation and the evaluation findings are not yet available.A supplemental report will be submitted upon completion of the evaluation.The device service history record review is pending and the results will be submitted in a supplemental report when available.

Event Description

It was reported that there was a hemosphere hem1 monitor that was being used during patient monitoring when the cco reading became frozen on the display screen for one hour.The sv02 reading was grayed out.The clinicians unplugged the cables and re-attached, but that was unsuccessful to get the monitor to proceed.They power cycled the monitor, but that still did not help.They exchanged the suspect hem1 monitor for another monitor and then were able to continue without further incident.There was no inappropriate patient treatment administered.There was no patient harm or injury.The patient demographic information was requested and was not provided.

Manufacturer Narrative

One hemosphere instrument monitor was received for product evaluation.The unit was tested per the system verification testing.It was observed and left to run for 48 hours.The co values and the sv02 values remained within appropriate parameters.An external inspection was performed and there was no physical damage identified.To reset the unit, it was found that the som processor needed replacement.There was no defect found.The device service record review was completed and all manufacturing inspections passed with no non conformances.The reported issue of inaccurate values was not confirmed by evaluation.There is no evidence or indication that a manufacturing defect is responsible for the issues; therefore no corrective action was taken.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make treatment decisions.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.In this case it is unknown if user or procedural factors played a part in this event.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.Udi (b)(4).

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: HEMOSPHERE INSTRUMENT MONITOR
• Type of Device: HEMOSPHERE INSTRUMENT MONITOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8161983
• MDR Text Key: 131380624
• Report Number: 2015691-2018-05257
• 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
• Report Date: 11/21/2018

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: 05/05/2023
• Device Model Number: HEM1
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 01/09/2019; 07/23/2020
• Supplement Dates FDA Received: 01/29/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1