MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT/MONITOR

Model Number HEM1

Device Problem Incorrect Measurement (1383)

Patient Problem Reaction (2414)

Event Date 10/25/2020

Event Type  malfunction  

Manufacturer Narrative

The product has arrived for evaluation; however, the findings are not yet available.When the evaluation is completed the findings will be submitted in a supplemental submission.The device history record review was completed and all manufacturing inspections passed with no non-conformances.The 70cc2 cable, sg module and sg catheter mdrs will be submitted separately.Their submission numbers are not available.When they become available a supplemental submission will be sent with the submission numbers.The udi information is (b)(4).

Event Description

It was reported that during use there were inaccurate values that displayed on the hemosphere instrument.A 70cc2 cable, swan ganz module and swan ganz catheter were involved and could not be ruled out.The patient had a swan ganz catheter inserted to monitor the status of the protamine reaction in the or.The protamine treatment was due to bleeding.There was also increased pa pressure, decreased peripheral blood pressure, decreased 02 consumption, decreased co and a decreased heart rate.The patient was transferred to the icu after the drug reaction.This was at the end of open heart surgery.The swan was connected to the hemosphere instrument in the icu and the patient parameters were co: 1.6, ci: 0.6 and svr upwards of 3300.The clinician believed from the patient's appearance that the numbers should have been reading higher.The patient looked fine and was making urine.They treated the patient because of the protamine reaction and increased epinephrine and decreased the neo synephrine.The swan ganz catheter placement was confirmed by an x-ray and with the pa waveform.During this time it was reported that the sv02 reading was 40 with no sqi bars displayed or alarms present.The co/ci was not alarming to indicate an issue.The next day the flotrac was connected and the parameters did not match with the hemosphere; ft co: 4.5, hs co: 2.7.The clinicians began using the flotrac to treat the patient instead of the sg catheter.The next morning the patient was doing fine.In the evening the patient began to decompensate and passed away.The clinician performed some fick calculations for co, ci and sv and they didn't match the data points with the swan and the hemosphere.They are not alleging that the inaccurate values contributed to the death of the patient.They are reporting the inaccurate values given by the swan ganz catheter and the hemosphere instrument and between the hemosphere and the flotrac.

Manufacturer Narrative

Medwatch submission number for 70cc2 cable 2015691-2020-14429.Medwatch submission number for sg module 2015691-2020-14430.Medwatch submission number for sg catheter 2015691-2020-14454.The product has arrived for evaluation; however, the evaluation is not completed.Once the findings are available a supplemental report will be submitted.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.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to the complaint.

Manufacturer Narrative

One hem1 instrument/monitor, sg module and 70cc2 cable were returned for product evaluation together.The devices were tested per high level system testing and there were no issues found.They passed the tests.The diagnostic log data was analyzed and found to be normal.There was no evidence of a malfunction or fault messages that were observed.There was no anomaly found.The clinical log data was analyzed and it showed that the patient was first monitored using swan ganz technology on one day and the next day it was switched to flotrac technology.Graphing the data, the difference in co values can be seen during the change between monitoring technologies.There are several mitigating circumstances that were present that could have contributed to the perceived inaccurate values.The reported issue was not confirmed by evaluation.At this time a root cause is not able to be determined as the patient had a medication reaction and was given medication to resolve that reaction.The devices were found to be functional as per the diagnostic log data.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.

• Brand Name: HEMOSPHERE INSTRUMENT/MONITOR
• Type of Device: HEMOSPHERE INSTRUMENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10845295
• MDR Text Key: 220975449
• Report Number: 2015691-2020-14428
• 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: 10/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SG MODULE, 70CC2 CABLE, SG CATHETER, FLOTRAC DEVIC
• Patient Outcome(s): Required Intervention