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

Model Number HEM1

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

The serial number of the device is unknown; therefore, the facility is unable to determine the exact unit involved.There will be no product return.The device history record review could not be completed as the serial number is unknown.The submission numbers for the sg module and sg catheter will be submitted under a supplemental report when they become available.

Event Description

It was reported that during use with a hemosphere instrument/monitor (hem1), swan ganz module (sgm) and swan ganz catheter there were unstable co/ci readings obtained.The issue could not be isolated to one of these devices.The readings for cardiac output were up and down between 3.8 to 7.7 within 10 minutes.The clinicians saw the unstable numbers.There were no error messages observed.This was occurring while the patient was sitting in a chair.There was no intervention with drips, fluid, etc.This was a heart transplant patient.There were no patient complications reported.The patient demographic information was not provided.The serial numbers of the hem1 and sgm were not documented by the facility.The exact equipment is unable to be determined; therefore, there is no product return.In addition, the sg catheter involved was discarded by the facility.

Manufacturer Narrative

The medwatch submission number for the sg catheter is 2015691-2020-14764.The medwatch submission number for the sg module is 2015691-2020-14732.This hem1 product will not be returned for evaluation as the serial number was not documented by the facility and it is unknown which unit to attribute the issue to.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

Further investigation found that after reviewing the information available and the images, that the large variation in sco (stat co) is to be expected in this scenario.When there is thermal stability introduced due to extraneous factors like infusions, positional adjustments, the expectations is that the stat values will react faster.Since it was reported that the patient was sitting up and possibly moving, this movement may add noise to the thermal signal causing the sco values to vary in large steps as the averaging duration for sco is short.Hemosphere provides cco parameter with longer averaging time to average out these large changes seen in sco.In conclusion, this would not be an event related to the catheter malfunctioning.

• Brand Name: HEMOSPHERE INSTRUMENT/MONITOR
• Type of Device: HEMOSPHERE MONITOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10906903
• MDR Text Key: 220976336
• Report Number: 2015691-2020-14718
• 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: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• 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: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SG MODULE, SG CATHETER.