MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT MONITOR; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor can a root cause or any potential contributing factors be identified.No actions will be taken at this time.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.The device history record review in process but hasn't been completed.Once the results are available, a supplemental report will be submitted.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Heart rate readings should correlate with the patient¿s clinical manifestations.These devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.These devices are typically used in intensive care units or operating rooms where patients are closely monitored.It is unknown whether any user or procedural factors contributed to 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 part of this monthly review.No corrective or preventative actions are required at this time.

Event Description

As reported, during use in a patient with a swan ganz catheter, the heart rate values displayed on the hemosphere monitor were higher than the values on the phillips bedside monitor.The expected values versus the displayed values are unknown.This case was also observed on a different patient, therefore, additional cases were opened.There was no allegation of patient injury.Demographic information requested but not provided.Unfortunately, the devices were not available for evaluation.

Manufacturer Narrative

The product was not returned for evaluation but the diagnostic logs were received.After analyzing the diagnostic logs, it was concluded that there is no problem with the signal that is being sent to the hemosphere from the phillips monitor.It was found that the discrepancy between the displayed hemosphere heart rate and the phillips heart rate was due to the differences in the heart rate averaging.The hemosphere heart rate was being averaged longer (as designed) than the phillips heart rate.The discrepancy was observed when the heart rate changed drastically and the hemosphere heart rate did not change/adapt as quick due to its averaging period.

Manufacturer Narrative

Expiration date added.

Manufacturer Narrative

A device history record review was completed and documented that the device met all specifications upon distribution.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: HEMOSPHERE INSTRUMENT MONITOR
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8191029
• MDR Text Key: 131496335
• Report Number: 2015691-2018-05531
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: HEM1
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1