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

Model Number MERGE CARDIO V10.0

Device Problem Data Problem (3196)

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

Event Date 03/31/2020

Event Type  malfunction  

Manufacturer Narrative

An investigation identified an error in the calculations for michigan reference ranges and z-scores.Merge healthcare / (b)(4) is working with the pediatric echo knowledge base supplier ascend in order to complete the investigation.The investigation is ongoing and when more information becomes available, a supplemental report will be filed.At this time there are no allegations of patient impact or harm due to the error in the calculated z-scores.

Event Description

Merge cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from merge healthcare and other vendors systems including images, hemodynamic studies and reports, measurements (via import from (b)(4) structured reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.Merge cardio is intended to allow users to review diagnostic and non-diagnostic quality images, annotate studies, perform digital subtraction on images, to perform quantitative measurements on images (including but not limited to quantitative coronary analysis, left ventricular analysis, time, area, length, velocity, angle, volume, and velocity-time integrals), to generate physician generated clinical reports (via structure reporting and template based tools), and to store this information in a database.On (b)(6) 2020, merge healthcare was performing internal testing of a new 5.X pediatric echo knowledge base file for michigan z-scores.It was found that while testing this version 5.X file and comparing with the previously released version 3.X file for michigan z-score calculations, that there was a difference between the two.Both the internal merge healthcare investigation and the paediatric echo knowledge base supplier ascend's investigation concluded that there was an error and that the michigan reference ranges and z-scores are not calculating correctly.For customers using a 3.X version of the ascend pediatric echo knowledge base to calculate michigan z-scores, there is a potential for a misdiagnosis which may lead to patient harm.However, there have been no reports of patient injury or harm as a result of this issue.Reference complaint-(b)(6).

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 04/24/2020.On (b)(6) 2020, merge healthcare was performing internal testing of a new 5.X pediatric echo knowledge base file for michigan z-scores.It was found that while testing this version 5.X file and comparing with the previously released version 3.X file for michigan z-score calculations that there was a difference between the two.Both the internal merge healthcare investigation and the pediatric echo knowledge base supplier's (ascend) investigation concluded that there was an error and that the michigan reference ranges and z-scores were not calculating correctly.These reference ranges are calculated by the supplier's (ascend) database that is installed with the merge cardio product.The supplier (b)(4) confirmed that there is a defect in their 3.X database's calculation of (b)(6) reference ranges on 4/21/2020.Ascend's 3.X version of their pediatric echo knowledge base calculates michigan reference ranges incorrectly.This defect results in wider than expected upper and lower limit reference ranges.Therefore, when a patient's z-score, for a particular measurement, is evaluated against the range, a false negative may be indicated by the wider range of acceptable reference range values.As a result of this reference range miscalculation, there is a potential for a misdiagnosis which may lead to patient harm.At this time there are no allegations of patient impact or harm due to the error in the calculated reference ranges.Merge healthcare's investigation confirmed that the defect resides within supplier ascend's 3.X database.This database is installed with merge cardio customers requesting reference ranges & z-scores for pediatric cardiology.As a result of the investigation, merge healthcare is voluntarily conducting a field action or recall: 2183926-05/06/2020-001-c 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: g7 - indication that this is follow-up report 001.H1 - indication of malfunction as reportable event.H3 - indication that device evaluated by manufacturer.H6 - evaluation codes: results code: 3049.Conclusions code: 4307.H7 - remedial action of recall.

• 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
• MDR Report Key: 9997097
• MDR Text Key: 199903156
• Report Number: 2183926-2020-00016
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K051649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE CARDIO V10.0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2183926-05/06/2020-001-C
• Patient Sequence Number: 1