MAUDE Adverse Event Report: EPOCAL INC. EPOC BLOOD ANALYSIS SYSTEM; ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Model Number HR-1002-00-00

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2023

Event Type  malfunction  

Event Description

A customer alleging inconsistent hemoglobin results from siemens epoc device.There was no report of injury due to this event.

Manufacturer Narrative

Siemens has requested more information and instrument data files for investigation.Customer has alleged inconsistent hemoglobin readings on siemens epoc device during cabg medical procedure.Customer alleges unnecessary medical procedure or treatment by transfusing blood if they see low hb readings while understanding the risks of giving unnecessary transfusion.Customer also alleges no harm as transfusion was not necessary.The cause of this event is unknown.

Manufacturer Narrative

Siemens requested more information and instrument data files for further investigation.Insufficient information was received from the customer.The cause of the hematocrit (hct) and hemoglobin (hgb) inconsistency could not be determined from the information provided by the customer.Epoc calculated hgb is derived from the hematocrit (hct) reading on the epoc device.As per section 12.16.6 of the epoc system manual; hemoglobin concentration is calculated from the measured hematocrit according to the relation: chgb (g/dl) = hct (decimal fraction) x 34.Given this relation, the investigation focused solely on hct performance of the card lot 03-23067-50.The in-house performance of hct for the card lot in question, 03-23067-50, did not identify any product deficiencies.Card lot 03-23067-50 was tested with blood and with aqueous control fluids at the time of product release.Card lot 03-23067-50 met product specifications at the time of release.Additional testing data was available on card lot 03-23067-50 and no issues were identified.Therefore, there is no evidence from in-house test data that the system or reagent cards are not performing as intended.The cause of this event is unknown.

• Brand Name: EPOC BLOOD ANALYSIS SYSTEM
• Type of Device: ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• Manufacturer (Section G): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 17373668
• MDR Text Key: 319780188
• Report Number: 3002637618-2023-00051
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 00809708016685
• UDI-Public: 00809708016685
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K200107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HR-1002-00-00
• Device Catalogue Number: 10736398
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 08/10/2023
• Supplement Dates FDA Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1