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

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.

• 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 Key: 6524650
• MDR Text Key: 73780002
• Report Number: 3004959793-2017-00001
• Device Sequence Number: 1
• Product Code: CGL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113726
• Number of Events Reported: 1
• 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

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HH-1R09-00-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Weight: 118