MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE PACS; PICTURE ARCHIVING COMMUNICATION SYSTEM PACS

Model Number MERGE PACS 8.1, 8.1.1, 8.1.2

Device Problems Computer Software Problem (1112); Application Program Problem: Parameter Calculation Error (1449)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2020

Event Type  malfunction  

Event Description

Merge pacs is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings.Merge pacs processes and displays medical images from dicom-compliant modalities.The device is designed to enable efficient workflows by maintaining clinicians' worklists and retrieving and managing studies for reading, reporting, communication, and storage.Merge pacs software runs on off-the-shelf computer hardware and can be configured to operate standalone or to integrate with vendor-neutral imaging archives (vnas) such as iconnect enterprise archive (icea) for image storage, and with radiological and hospital information systems (ris and his) and medical record systems (emr, ehr, etc.).On (b)(6) 2020, merge healthcare received a report from a customer that hounsfield unit values reported in the 3d view were inconsistent with the hounsfield unit values reported in the 2d view of merge pacs.Upon investigation, it was discovered that pixel value measurements (including hounsfield unit measurements and suv measurements) from the probe, roi, and region analysis area tools are incorrect on multi-planar reformats (mprs) generated by merge pacs.The issue is noticeable when a modality acquires a series of images and sends the images to merge pacs.The radiologist then generates additional planes such as sagittal or coronal using mpr.Measurements done on the merge pacs generated mpr's may have incorrect measurements.Incorrect pixel measurements may result in the implementation of an incorrect or unnecessary treatment plan that could result in the patient receiving unnecessary medication, change in dosage of existing medication, or unnecessary medical procedures.Based on this, there is a potential for delay in treatment that could cause harm to the patient.There have been no reports of patient injury or harm as a result of this issue.(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 08/06/2020.After further investigation, it was determined that this issue is caused by a software defect and was introduced in merge pacs 8.1.Prior to 8.1, when the user drew a measurement on an mpr, the measurement was performed on the 3d image itself.In 8.1 this was changed so that the location where the user clicked on the mpr was used to query the original 2d images for their pixel values.The algorithm used to query for the 2d pixel values had an assumption that the orientation of the mpr was represented by the identity matrix.If the mpr was transformed into a different orientation, the tool would query for the pixels in the wrong position of the 2d images.During testing, most tests were performed on mprs with the identity orientation.Given the nature of the data, measurements other orientations may have returned the same data because they are largely homogeneous with some small structures in them.Testing with more data in more orientations helped to determine the problem.A fix was released in version 8.1.3 on 14-aug-2020.No further action is required.There were no reports of death, serious injury or injuries that were directly caused or contributed to as a result of this issue.H6 - evaluation codes: health effect - clinical code 4582 no clinical symptom/sign.Health effect - impact code 2199 no health consequences or impact.Medical device problem code 1449 application program problem: parameter calculation error.Type of investigation 10 testing of actual/suspected device.Investigation findings 618 incorrect algorithm.Investigation conclusions 12 cause traced to device design.

• Brand Name: MERGE PACS
• Type of Device: PICTURE ARCHIVING COMMUNICATION SYSTEM PACS
• Manufacturer (Section D): MERGE HEALTHCARE; 911 walnut ridge drive; hartland, wi
• MDR Report Key: 10375493
• MDR Text Key: 202053030
• Report Number: 2183926-2020-00031
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00842000100805
• UDI-Public: 00842000100805
• Combination Product (y/n): N
• PMA/PMN Number: K192455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE PACS 8.1, 8.1.1, 8.1.2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2944-2020
• Patient Sequence Number: 1