MAUDE Adverse Event Report: AGFA HEALTHCARE CORP. IMPAX CV12; IMPAX CARDIOVASCULAR (CV12) PICTURE ARCHIVING AND COMMUNICATION

Model Number IMPAX CV12

Device Problems Computer Software Problem (1112); Nonstandard Device (1420)

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

Event Date 04/20/2015

Event Type  malfunction  

Event Description

The customer reported to agfa on (b)(6) 2015 they were experiencing an issue with incorrect demographics with cv reports crossing into their epic system.Demographics manager had been installed (b)(6) 2015 and the site discovered the name on a cv report had been changed on the.Pdf report.The his_data for the patient was correct, but the patient name at the top of the document was another cv patient.Investigation revealed you can go into the patient in results management and select show report and all of the information on the report is correct including the patient name.A full reprocess of potentially affected reports was performed by agfa technical support.The root cause has been identified as a product defect within the demographics manager component of impax cv 12.1.Demographics manager must be enabled for this situation to occur.A polling timer within (dm) calls a function.This function processes the dm work.The function does a self-check to see if it is already busy before it starts processing the next set of work.If it is already busy, it skips the work but sets itself to "not busy" which is wrong because it is in fact "busy".This defect then is that the function sets itself to "not busy" when in fact it is "busy".The consequence of this is that the next time the polling timer calls the function, the function self-check comes back as "not busy" (which is wrong) and if it is in the middle of processing a report, that work will be stopped, the new work will be started, and the processing may have some objects populated with another report's data.Agfa solution development is underway and a correction will be implemented for this issue.There has been no reported patient harm for this event.

Event Description

Root cause as a product defect within the demographics manager component of impax cv.However, the patient demographic data may change after the report is signed and this new information should be reflected in those previously-signed system reports.The demographics manager updates previously signed reports (xml and pdf files) with the revised patient demographics information and resends the information to the proper external systems.The demographics manager is able to revise the reports without having physicians re-sign their previously signed reports.The demographics manager service will always regenerate the pdfs of all signed reports for a patient and/or study.The archive versions of the report are the two copies of xml files located on the report storage server and the backup server.A product defect in the demographics manager code may cause some reporting objects to be populated with another report's data causing misattribution.Under normal configuration/operation, the dm service finishes the demographic updates within a 120 second window.If however a large number of jobs are queued up and they do not finish processing within the 120 second window, misattribution may occur.On september 1, 2015, agfa implemented a correction via agfa id - rrc 15-003 (1225058-09-01-2015-001-c) mandatory service bulletins have been released to provide documentation on how to deploy the correction for demographics manager (dm) for sites with (b)(4) and (b)(4) installed.

• Brand Name: IMPAX CV12
• Type of Device: IMPAX CARDIOVASCULAR (CV12) PICTURE ARCHIVING AND COMMUNICATION
• Manufacturer (Section D): AGFA HEALTHCARE CORP.; 1 crosswind rd; misquamicut RI 02891
• Manufacturer (Section G): AGFA HEALTHCARE CORP.; 1 crosswind rd; misquamicut RI 02891
• Manufacturer Contact: deborah huff ; 10 south academy street; greenville, SC 29601 ; 8644211754
• MDR Report Key: 4771374
• MDR Text Key: 5777828
• Report Number: 1225058-2015-14120
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: IMPAX CV12
• Device Catalogue Number: CV12.1
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1