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

Model Number MERGE HEMODYNAMICS 9.40.3

Device Problems High Readings (2459); Output Problem (3005)

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

Event Date 07/06/2016

Event Type  malfunction  

Manufacturer Narrative

The customer informed merge technical support that a similar problem occurred in another lab at their site and it was caused from a faulty link assembly on the pdm (patient data module).Tech support sent the customer the replacement hardware on (b)(6) 2016 and it was confirmed that the problem was corrected.The alleged faulty hardware was received by merge healthcare for evaluation on (b)(6) 2016.An evaluation of the unit showed that there were no problems with it.The hemo user manual, addresses the potential for such an occurrence by providing instructions on how to use the merge-supplied simulator to aid in troubleshooting.For this reason, (b)(4) (human factors issue) was used.

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 they experienced high ecg output values when using the link assembly.Information obtained from the customer revealed that the problem resulted in ffr (fractional flow reserve) data not being obtained.The procedure was completed successfully without the data; however, the attending physician was not able to place a stent.The patient was placed on "medical management" through medication and scheduled to return in ninety (90) days to re-do a stress test.Depending on the results of the test, the patient may undergo a heart catheterization procedure again to place a stent.With merge hemo not presenting physiological data during treatment, there is a potential for incorrect treatment that results in harm to the patient.(b)(4).

Manufacturer Narrative

This supplemental report is submitted to the fda to provide more information concerning this event as reported by merge healthcare in the initial report submitted 06aug2016.In the initial report, it was stated that high ecg values were obtained during a ffr (fractional flow reserve) procedure.As a result, the procedure was completed without the use of ffr.The potential impact to a patient has been reviewed and the risk level has been assessed as medium risk.Additionally, a low number of customers have reported this issue therefore reducing the frequency of occurrence.Ffr is an optional feature of merge hemo and is used as a secondary diagnostic method that may be used in conjunction with an angiogram where the clinician will visualize the lesion to determine if interventional treatment is required.Interventional treatment during cardiac catheterization also takes other factors into account such as medical history, symptoms, and risk factors.The ffr calculation is based on the ratio of the mean distal pressure and mean proximal pressure, which are displayed to the clinician simultaneous to the ffr calculation.An erroneous ffr calculation in the absence of an incorrectly calculated proximal and distal arterial pressures would be visibly apparent to the clinician.In follow-up communication with the customer on 07may2018, it was found that the site uses st.Jude ffr and have not purchased merge integrated ffr system.Merge technical support shipped the customer a replacement v2 4p link assembly on (b)(6) 2016 at their request because a similar issue was reported to merge healthcare on 09may2016 ((b)(4)) and a replacement link assembly was installed and reportedly corrected the issue and occurred when no patient was present.The evaluation results showed that no problems were found with the returned unit.Likewise with this complaint, the unit was returned to merge healthcare on 21jul2016 for evaluation.The results showed no issue with the returned link assembly after testing was conducted.A review of the customer's hemo case management within merge healthcare's internal database found that the customer has called in again on various occasions reporting the same issue and involved damaged hardware and request for assistance in testing the pdm (patient data module) and thermo cardiac output.Both of which were found to operate as expected.No further actions are anticipated at this time due to the issue being visibly apparent to the clinician, the low number of customer complaints, and the moderate to low impact on patients since ffr is a secondary diagnostic method.

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• MDR Report Key: 5852531
• MDR Text Key: 51387431
• Report Number: 2183926-2016-00676
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K082421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 9.40.3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2016
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ST. JUDE FFR