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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPOCAL INC. EPOC BLOOD ANALYSIS SYSTEM; EPOC BLOOD ANALYSIS SYSTEM, PRODUCT CODE: CGL

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EPOCAL INC. EPOC BLOOD ANALYSIS SYSTEM; EPOC BLOOD ANALYSIS SYSTEM, PRODUCT CODE: CGL Back to Search Results
Catalog Number HH-1R09-00-00
Device Problems Display or Visual Feedback Problem (1184); Device Stops Intermittently (1599)
Patient Problem Death (1802)
Event Date 03/27/2017
Event Type  Death  
Manufacturer Narrative
The epoc host (hh-1r09-00-00) with s/n (b)(4) is expected to be returned and will be evaluated during the investigation as pertaining to the event.A supplemental report will be submitted accordingly.
 
Event Description
It was reported to epocal on 28-mar-2017 (case number (b)(4)) that the epoc host (hh-1r09-00-00) with s/n (b)(4) froze during testing on a patient experiencing a code blue medical emergency.The patient was declared deceased.The initial reporter stated: "the epoc host failure caused: failure in proper patient care.The doctor needed blood gas results quick and after the blood was in machine, respiratory therapy, the doctor and nurses were all waiting for results.After blood was done the machine froze up and i was unable to get results nor input any information in on the patients or what tests i wanted.I had to grab another machine which took extra time that we do not have during a code blue.The machine that i grabbed from icu worked very good and quick, per the phlebotomist." the patient a (b)(6) in-patient male experienced a code blue medical emergency, which began at approximately 19:36 on (b)(6) 2017.The patient had a medical history/diagnosis of: "acute on chronic systolic heart failure with ejection fraction 35%, cardiac shock, acute hypoxic respiratory failure due to previous listed." cpr was performed for approximately 40 minutes and the patient was declared deceased at 20:41 on (b)(6) 2017.The cause of death was "polymorphic ventricular tachycardia.Patient went in to asystole".Clarification on the initial statement: "the epoc host failure caused: failure in proper patient care", was requested.The customer responded on 06-apr-2017, stating what she thinks the phlebotomist meant: "the phlebotomist was not able to give results to the doctor when he wanted them.However, cpr was in progress".The epoc host (hh-1r09-00-00) with s/n (b)(4) is expected to be returned for manufacturer investigation.The investigation is underway.An internal medical review determined that in a situation where a patient with known chf suffers cardiac arrest due to polymorphic ventricular tachycardia, there is no role for blood gas or laboratory results.As such, there is no information to suggest that the delay in receiving a result due to the frozen epoc caused or contributed to the patient death.However, the event is being conservatively reported based on the statement provided by the customer and the limited clinical information available in the case.
 
Event Description
Following the initial mdr that was submitted on 26-apr-2017, patient medical records were subsequently obtained and an internal medical review was conducted.The patient was noted to have a potassium level of 4.3 meq/l shortly before the cardiac arrest with an identical measurement during the code.The magnesium level earlier in the day was 2.1 mg/dl.Both of these levels are unremarkable and not likely to have contributed to decompensation.The abg obtained during the code demonstrated a ph of 7.25 with a pco2 of 73 and po2 of 227.This indicates a respiratory and metabolic acidosis.These findings are expected given his history of respiratory failure and lactic acidosis (7.5 mmol/l).These findings confirm that a delay to results was of no impact on the outcome of this case.The treatment rendered appears appropriate and it was not expected that any specific change in therapy could have changed the final outcome.
 
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Brand Name
EPOC BLOOD ANALYSIS SYSTEM
Type of Device
EPOC BLOOD ANALYSIS SYSTEM, PRODUCT CODE: CGL
Manufacturer (Section D)
EPOCAL INC.
855 brookfield road
ottawa, ontario K1V 2 S5
CA  K1V 2S5
Manufacturer (Section G)
EPOCAL INC.
855 brookfield road
ottawa, ontario K1V 2 S5
CA   K1V 2S5
Manufacturer Contact
german guzman
855 brookfield road
ottawa, ontario K1V 2-S5
CA   K1V 2S5
61328
MDR Report Key6524650
MDR Text Key73780002
Report Number3004959793-2017-00001
Device Sequence Number1
Product Code CGL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113726
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberHH-1R09-00-00
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/28/2017
Initial Date FDA Received04/26/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age66 YR
Patient Weight118
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