MAUDE Adverse Event Report: FUJIFILM MEDICAL SYSTEMS U.S.A., INC. SYNAPSE PACS; PICTURE ARCHIVING AND COMMUNICATION SYSTEM

Model Number N/A

Device Problems Programming Issue (3014); Patient Data Problem (3197)

Patient Problem Misdiagnosis (2159)

Event Date 01/22/2013

Event Type  No Answer Provided  

Manufacturer Narrative

Device operated as specified.Cause of event was user error.Initial error was manually inputting incorrect accession number for the patient.Secondary error was ignoring the anomaly alert.

Event Description

Fujifilm medical systems u.S.A., inc.(fmsu) recently completed a retrospective review of complaint files from 2013 through 2015 and has determined that this complaint meets the threshold for reporting.Fmsu is therefore reporting it at this time.An exam at (b)(6) hospital in (b)(6), was entered manually on the modality and the accession number was entered incorrectly by the technologist.As a result, the exam was sent from the modality to the patient exam folder in synapse matching the accession number that was entered.This patient folder however was not for the correct patient.Synapse has functionality designed to mitigate this type of event.When studies are received from a modality, synapse pulls the patient information from the dicom header.Synapse then tries to match the patient information, e.G., the patient id, patient name, etc.With the accession number.When synapse finds a possible mismatch it creates an anomaly alert.Anytime the exam is opened an anomaly alert will open on the user's monitor screen indicating that an anomaly exists for this exam.The anomaly alert identified in the event above would indicate "mismatch patient name." a screenshot of an anomaly alert is provided for your reference (this is not from the particular event).The user has the ability to select a checkbox not to show anomalies while in their current session which was done in this instance.After being notified of the anomaly and turning off the warning the radiologist still went ahead and dictated the results of patient a's exam to the patient b's exam folder; as a result there was an alleged misdiagnosis of patient b.Fmsu is not aware of whether treatment was provided on the basis of the misdiagnosis or of the outcome.Exams with anomalies are also copied to an anomaly folder.The pacs administrator should be reviewing the anomaly folder periodically to resolve anomalies.Or, as in this situation, the radiologist should have alerted the pacs admin that an anomaly needed to be resolved.A copy of the page from the operation manual showing the admin folder and anomaly sub-folder has been attached.The specific action of manually entering an incorrect accession number is clearly user error and synapse cannot prevent such an error from occuring.Synapse operated exactly as designed.

• Brand Name: SYNAPSE PACS
• Type of Device: PICTURE ARCHIVING AND COMMUNICATION SYSTEM
• Manufacturer (Section D): FUJIFILM MEDICAL SYSTEMS U.S.A., INC.; 419 west avenue; stamford CT 06902
• Manufacturer (Section G): FUJIFILM MEDICAL SYSTEMS U.S.A., INC.; 419 west avenue; stamford CT 06902
• Manufacturer Contact: arye hess ; 419 west avenue; stamford, CT 06902 ; 2036023652
• MDR Report Key: 5128810
• MDR Text Key: 27526803
• Report Number: 2443168-2015-00004
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Report Date: 10/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other