MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE HEMODYNAMICS; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number MERGE HEMODYNAMICS 9.30

Device Problem Device Operational Issue (2914)

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

Event Date 06/30/2016

Event Type  malfunction  

Manufacturer Narrative

Troubleshooting efforts are still underway to determine the reported problem.When more information becomes available, a supplemental report will be submitted.

Event Description

Merge hemodynamics monitors, measures, and records physiological data from a human patient undergoing a cardiac catheterization procedure.The system comprises the patient data module and the merge hemodynamics hemo monitor pc.The two units are connected via a serial interface.All vital parameters and evaluations are registered and calculated in the patient data module.This data is then transmitted to the merge hemodynamics hemo monitor pc via the serial interface.All data can be shown and monitored on the merge hemodynamics hemo monitor pc.On (b)(6) 2016, a customer reported to merge healthcare that negative pressure waveforms were present during an active case after the fractional flow reserve (ffr) device was zero pressured.Information obtained from the customer revealed that the negative pressure waveforms were intermittent when used with the ffr 3rd party device.With merge hemo not capturing physiological data, there is a potential for incorrect treatment that results in harm to the patient.However, the customer reported that the procedure was completed successfully without using ffr.(b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda in accordance with the applicable regulations and as indicated by merge healthcare in the initial report submitted 01aug2016.Merge technical support attempted to reach the customer on three separate occasions to troubleshoot their reported issue.However no attempts were successful in reaching the customer.A quick guide for using st.Jude medical pressure wire aeris is provided to customers who use the optional feature, ffr (fractional flow reserve).The following steps are provided to medical staff: verify the pressurewire receiver is plugged into p3.Double click or drag ffr procedure from template into chron log.Label/select aortic channel as pressure 1 and distal channel as pressure 3.Label/select aortic location as 'ao' and distal location as 'wire' or 'dst-a'.(this labeling will allow the distal location pressure tracing to display in a pink color to differentiate it from the ao in red).Zero pressure channel 1 and zero pressure channel 3.Flush the pressurewiretm aeristm in the hoop.Press quickly on the center connect button to activate receiver.Push the sliding button on the pressurewiretm aeristm forward to zero and connect with receiver.Select 'show' in the ffr action editor and the ffr mode will activate.Click on equalize once the pressurewiretm aeristm is advanced outside the guide and proximal to the lesion.Verify you get 1.0 before proceeding.Verify the wire introducer is removed and the toughy is closed.Start recording after the pressure wiretm aeristm is advanced beyond the lesion press stop when you are finished or allow the recording to continue the entire time set for the recording.Note: the "live" ffr value is an average of beats selected in settings>pressure tab and may not reflect the lowest individual ffr value during the "live" recording.A value of '0' in settings will average the recording ffr value over 6 seconds.After the recording is complete the computer will scan the entire ffr waveform recording and select the lowest individual ffr value on the waveform.Review the recorded ffr waveform and if needed, select the desired ffr value by moving the ffr transition label at the bottom of the recording left or right.Additional beats may be added by a single left click on any individual beat in the recording.All highlighted beats will be used in the averaged ffr value.

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: meg mucha ; 900 walnut ridge drive; hartland, WI 53029 ; 2623670700
• MDR Report Key: 5835910
• MDR Text Key: 50814558
• Report Number: 2183926-2016-00667
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 9.30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2016
• Initial Date FDA Received: 08/01/2016
• Supplement Dates Manufacturer Received: 05/06/2018
• Supplement Dates FDA Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2016
• 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
• Treatment: ST. JUDE FFR DEVICE (ARIS)