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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.
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Manufacturer (Section D)
one edwards way
irvine CA 92614
Manufacturer (Section G)
one edwards way
irvine CA 92614
Manufacturer Contact
jessica atallah
one edwards way
irvine, CA 92614
MDR Report Key10845295
MDR Text Key220975449
Report Number2015691-2020-14428
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
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 Received11/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHEM1
Device Catalogue NumberHEM1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/05/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/16/2020 Patient Sequence Number: 1