MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE CARDIO; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS

Model Number MERGE CARDIO V10.3.1

Device Problems Computer Software Problem (1112); Patient Data Problem (3197)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2018

Event Type  malfunction  

Manufacturer Narrative

It has been found that in merge cardio version 10.3 workstation with tomtec vtta2.20.10, secondary captures failed to save originally.After opening a second patient and saving secondary captures for that patient, the secondary captures for the first patient saved to the second patient.These captures are then saved into merge cardio under the wrong patient and this was not readily apparent to the user.The ea team performed a search and this was the only time that this has occurred.Tomtec should have been upgraded to vtta2.21.06 at the same time that cardio was upgraded to v10.3 but was missed on a couple of workstations and this issue was able to be reproduced on the workstations with cardio v10.3 and tomtec vtta2.20.10.Tomtec was upgraded to vtta2.21.06 and since this issue has not been able to be reproduced.Currently, this issue is still being evaluated by cardio engineering in vrcs-18188 and tomtec has indicated that they will be filing an mdr with the fda for this issue as well.Further analysis has identified the issue with tomtec, a bug that exited in version tta 2.12.09 (shipped with cardio 10.2), still persisted in version tta 2.20.10 (shipped with cardio 10.2 patch 1), and later fixed in tta 2.21.06 (this version was validated by ibm for cardio 10.2, 10.3 and 11.0).Tomtec tta2.20.10.(b)(6) is impacted.Also possibly any customer who was at some point on versions tta2.20.10 (shipped with cardio 10.2 patch 1) and tta2.12.09 (shipped with cardio 10.2).Customer impact is still being determined at this time.A supplemental report will be filed when additional information becomes available.

Event Description

Merge cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, hemodynamic studies and reports, measurements (via import from dicom structured reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.The merge cardio and tomtec integration allows users to view medical images in the tomtec client (imagecom) on a merge cardio workstation without having to manually enter patient or study information into the tomtec application.Imagecom is a clinical application package for high performance pc platforms based on microsoft windows operating system standards.Imagecom is software for the retrieving, reviewing, measuring, and reporting of dicom data, for the us.In this integration, the modality sends all studies containing a valid accession number to the enterprise archive (ea).Imagecom is invoked from the merge cardio workstation.The modality sends all studies to the enterprise archive.Secondary capture (sc) or structured report (sr) images are sent back an integration application, i.E.Tomtec, from to the ea.Sc images can be viewed in merge cardio.On (b)(6) 2018, it was found that secondary captures in tomtec were saving under the wrong patient in merge cardio.Images saving under the wrong patient to lead to patient harm by incorrect or mistreatment of the patient.(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 08/15/2018.Support request vrcs-17998 tomtec secondary capture saves onto a different patient's study was closed on 8/28/2018.Customer issue was resolved by updating all workstations to tomtec version tta2.21.01.Post market product issue assessment vrcs-18188 found that the root cause of this issue was due to third party software coding defect in tomtec tta 2.20.10.This defect was corrected in tta 2.21.01.Merge did not conduct an hhe as this is an oem (tomtec) issue and not an issue within merge cardio.Tomtec provided merge with a risk assessment and hhe via scar qs-146596.Tomtec also submitted an mdr for this issue 8043836-2018-00002 with no indication of patient harm.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.Revised information contained in this supplemental report includes the following: evaluation codes: method code: 10 testing of actual/suspected device.Results code: 213 no device problem found.Conclusions code: 4310 cause cannot be traced to device.Indication of additional manufacturer information is contained in this follow-up report.

• Brand Name: MERGE CARDIO
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 7787850
• MDR Text Key: 117579715
• Report Number: 2183926-2018-00076
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00842000100041
• UDI-Public: 00842000100041
• Combination Product (y/n): N
• PMA/PMN Number: K051649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE CARDIO V10.3.1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1