MAUDE Adverse Event Report: EPOCAL INC. EPOC HOST

Catalog Number 10736387

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2020

Event Type  malfunction  

Manufacturer Narrative

The patient's wristband was corrected, but the results in the epoc and edm were still mismatched to another patient.The customer called into siemens technical solutions to determine if and how patient results can be edited, however, the customer was told that only a comment can be added to describe the event.No lab tests were performed on the other baby.There is no allegation of any harm or adverse events and no patient results or treatments were affected.The system is operational and the event is classified as a use/user error (accidental misuse).

Event Description

The customer stated a nicu nurse drew a heel stick sample and ran an epoc cap-care tube, pt.Id# (b)(6).The results were not transferring over into the patient's chart (powerchart emr), and it was then discovered that the patient had another patient wristband on, pt.Id# (b)(6).The incorrect barcode was scanned.The patient's wristband was corrected, but the results in the epoc and edm were still mismatched to another patient.There were no lab tests performed on the other baby.No treatment or lack of treatment occurred as a result of the user error.

• Brand Name: EPOC HOST
• Type of Device: EPOC
• 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 ; 7052212
• MDR Report Key: 9765338
• MDR Text Key: 182564762
• Report Number: 3002637618-2020-00007
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00809708052898
• UDI-Public: 00809708052898
• 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: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10736387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2020
• Was Device Evaluated by Manufacturer?: No
• 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