MAUDE Adverse Event Report: MERGE CADSTREAM; IMAGING PROCESSING SYSTEM

Model Number 6.2.2.1184

Device Problem Use of Device Problem (1670)

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

Event Date 08/03/2021

Event Type  malfunction  

Event Description

Cadstream is intended to be used in the visualization, analysis, and reporting of magnetic resonance imaging (mri) studies.Cadstream supports evaluation of dynamic mr data acquired during contrast administration.Cadstream performs other user selected processing functions (such as image registration, subtractions, measurements, 3d renderings, and reformats).On 7/12/2021, a customer contacted merge healthcare to request assistance with re-prcessing images that were believed to be processed incorrectly.Support reviewed the incoming images and system remotely.Support found that the images appeared to be scanned with incorrect patient orientation.The customer confirmed the orientation of the images.Cadstream does not allow for the editing or modification of the original image.The customer has the ability to make annotations regarding the orientation, however, cadstream will continue to reflect the orientation as originally scanned on the processed images.Support instructed the customer regarding these images and orientation.The incorrect orientation is not a malfunction of the cadstream device nor is it a failure of the device to meet specification.The issue is use error caused originating at the mri scanner due to improper data entry.Merge healthcare currently has a request for cessation of reporting filed with the agency concerning this issue.This has the potential to delay patient treatment and/or diagnosis.There have been no reports of patient injury or harm as a result of this issue.Reference complaint (b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda in accord with applicable regulations and as indicated by merge healthcare in the initial report submitted 8/3/2021.As of (b)(6) 2021, merge healthcare is ceasing reporting on cadstream laterality issues.The issue in question presents when a technologist performing a scan enters the patient orientation marker incorrectly at the scanner ("l" if image is of the left breast, "r" if image is of the right breast, and not present if the image is of both breasts or the orientation cannot be determined).In order to preserve the integrity of an image series, cadstream does not allow for the editing or modification of the original images, including orientation.Beginning in 2016, due to scan results having the potential to become part of a patient's permanent record, and records have the potential to impact a patient's treatment, merge healthcare interpreted there to be a possibility for a misdiagnosis or mistreatment that could lead to harm due to this issue.This issue is caused by user error at the scanner and not caused by or contributed to by merge cadstream in any way.Review of this issue based on current knowledge of the device, clinical workflow, existing mitigations against user errors, and the presence of no death or injury associated with the issue at any point between 2016 and 2021 indicates that the device is operating as designed and that this issue presents remote likelihood of injury or harm to a patient.No further action is required.Revised information contained in this supplemental report includes the following: g3 - date new information received by manufacturer g6 - indication that this is follow-up report 001 h1 - indication of malfunction as reportable event h2 - indication of additional information h10 - additional narrative/data.

• Brand Name: MERGE CADSTREAM
• Type of Device: IMAGING PROCESSING SYSTEM
• MDR Report Key: 12271516
• MDR Text Key: 265185891
• Report Number: 2183926-2021-00019
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00842000100638
• UDI-Public: (01)00842000100638(10)6221184(11)180727
• Combination Product (y/n): N
• PMA/PMN Number: K092954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6.2.2.1184
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2018
• 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