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

Model Number MERGE PACS V6.4.5

Device Problems Computer Software Problem (1112); Device Issue (2379)

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

Event Date 02/25/2016

Event Type  malfunction  

Manufacturer Narrative

Merge pacs was operating as designed.All indications are that the issue of the merging of different patients was due to the customer's use of multiple ris systems.While there are ways for customers to minimize the chances of merging different patient's data, this customer was not utilizing those controls.

Event Description

Merge pacs is a picture archiving communication system that is intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.Pacs is designed and for soft copy reading, communication, and storage of studies produced by digital modalities.A customer contacted after hours merge healthcare support on (b)(6) 2016 and reported that a patient's order was merged with another patient's order.Merge healthcare support began investigating the issue and worked with the customer over multiple weeks.The investigation concluded on 3/25/2016 and determined that the site had been importing patient information from 2 different ris systems.This was determined to be a user error that contributed to the merging of 2 different patient's information.The site has discontinued sending patient information from the 2nd ris system.Merge pacs was functioning as designed for patient data interactions with one ris system; not multiple ris systems.This mdr is being submitted due to the potential for a possible misdiagnosis or mistreatment of a patient due to the merging of different patient's data.The customer did not indicate any harm or impact to a patient(s) due to the merging of patient information being imported from the customer's multiple ris systems into merge pacs.(b)(4).

• Brand Name: MERGE PACS
• Type of Device: PICTURE ARCHIVING COMMUNICATION SYSTEM (PACS)
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge dr; hartland WI 53029
• Manufacturer Contact: mike diedrek ; 900 walnut ridge dr; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5603941
• MDR Text Key: 43499254
• Report Number: 2183926-2016-00562
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE PACS V6.4.5
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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