MAUDE Adverse Event Report: FUJIFILM MEDICAL SYSTEMS U.S.A., INC. SYNAPSE CARDIOLOGY; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Device Problem Incorrect Measurement (1383)

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

Event Type  malfunction  

Event Description

Reportedly, an attending physician was interpreting an echocardiogram in synapse cardiovascular and was measuring doppler.The patient's heart rhythm was irregular, so the physician had to average doppler signal measurements for each valve.While doing doppler signal tracings of the mitral valve, he noticed that values that should have been constants in the calculations from the initial tracings would spontaneously change as more signals were averaged (specifically mean pressure gradients).Reportedly, this has been an ongoing issue that is currently being investigated by the manufacturer.Unknown how long this has been an issue and how many patients have been affected.

Manufacturer Narrative

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Event Description

Reportedly, an attending physician was interpreting an echocardiogram in synapse cardiovascular and was measuring doppler.The patient's heart rhythm was irregular so the physician had to average doppler signal measurements for each valve.While doing doppler signal tracings of the mitral valve, he noticed that values that should have been constants in the calculations from the initial tracings would spontaneously change as more signals were averaged (specifically mean pressure gradients).Reportedly, this has been an ongoing issue that is currently being investigated by the manufacturer.Unknown how long this has been an issue and how many patients have been affected.After additional internal review of 10% of 2017 echocardiogram patients, we discovered, in addition to the index case described above, there are three patients that could have been affected by this calculation discrepancy.Our review indicated significant differences between the software auto calculation of the mean pressure gradients of these three patients and the retrospective manual calculations completed by the physicians pursuant to our internal review.After an additional thorough medical record review, it has been determined that the three patients that could have been affected by this discrepancy have had the appropriate treatment.Treatment was not only determined by the results of the echocardiogram but also by independent clinical assessments.The synapse cardiovascular software has been in use here since 2001, however, our understanding is that the line of script in the program which does this calculation has been in place since 2009.The internal review is ongoing.

• Brand Name: SYNAPSE CARDIOLOGY
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): FUJIFILM MEDICAL SYSTEMS U.S.A., INC.; 3020 carrington mill blvd ste 500; morrisville NC 27560
• MDR Report Key: 7141870
• MDR Text Key: 95621040
• Report Number: 7141870
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/21/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2017
• Type of Device Usage: N
• Patient Sequence Number: 1