MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT; HEMOSPHERE INSTRUMENT (HEM1)

Model Number HEM1

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

The hem1 instrument will not be returned for product evaluation.However root cause investigation was performed in an attempt to replicate the issue and it was noted that there was incorrect implementation of software.This issue only occurs on the physiology cardio cerebral screen.The sto2 is the only parameter affected and the user can navigate away from the screen for the values to update.The software is being corrected.The device history record review was completed and all manufacturing inspections passed with no non-conformance's.The record of servicing has been reviewed and there is no previous related record.With any patient parameter displays, the 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 operators manual, the hemosphere advanced monitor is intended for use only in-patient assessment.This instrument must be used in conjunction with a bedside physiological monitor and/or patient clinical signs and symptoms.If hemodynamic values obtained from the device are not consistent with the clinical presentation of the patient, consider troubleshooting before initiating treatment options.In addition, clinicians should make treatment decisions based on all available patient information and not rely on one parameter for clinical course of action.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.Udi: #(b)(4).

Event Description

It was reported that during a target market release (tmr) at a facility for the hemosphere cx instrument that there was a discrepancy in st02 values that were displayed.The parameter tiles and the physiological screen readings were not the same.The readings displayed and readings expected are not available.The hem1 instrument was removed from the facility and is not available for product evaluation but the log files showed normal operation as the values for sto2 are being logged.There was no patient harm or injury reported.There was no inappropriate patient treatment reported.There is no patient demographic information available.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

Manufacturer Narrative

This supplemental submission for 2015691-2020-10260 is being submitted as a correction that this is not a reportable event.Clinicians using this technology would be monitoring patients closely in the or or icu.A frozen screen would alert the clinician to start the troubleshooting process.Only if the patient receives inappropriate or unintended treatment based on the parameters of the frozen screen would this be a reportable event.The product was not evaluated, since it was not returned.There was no inappropriate patient treatment.Administered.

• Brand Name: HEMOSPHERE INSTRUMENT
• Type of Device: HEMOSPHERE INSTRUMENT (HEM1)
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9623175
• MDR Text Key: 191838391
• Report Number: 2015691-2020-10260
• 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: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• 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?: No
• Date Manufacturer Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1