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

Model Number MERGE HEMODYNAMICS 10.0.4 PATCH 1

Device Problem Application Network Problem (2879)

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

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

The customer's reported problem, client pc had a critical error message, was internally investigated (hemo-11048) by merge healthcare.It was found by reviewing the event logs that an unhandled exception occurred when the customer attempted to view a patient's gradient values.Merge healthcare's engineering group along with technical support were able to re-create the error by clicking on gradients without having heart beats marked on an ao (aorta).Once the transition points were deleted, gradients could be viewed without errors.It was also found that the customer labeled both points as ao instead of lv/ao so the calculation only had ao/ao values.In follow up communication with the customer, they were advised to only mark valid transition points on a waveform recording to avoid this issue in the future.It was also found while reviewing the event logs that the client pc had a bad block on the hard drive which may have also contributed to the reported problem.The customer requested that only a replacement hard drive be sent instead of an entire client pc unit.Tech support created (b)(4) and a replacement 500 gb hard drive for a t3610 client pc was shipped to the customer on 06sep2017.The customer confirmed to merge technical support on 11sep2017 that upon replacement of the hard drive, the unit functioned as expected.A review of the customer's hemo case management within merge healthcare's internal database on 27sep2017 found that there have been no further call-ins by the customer regarding this issue.Merge healthcare engineering created a software fix for the reported issue.To date, no other customers have been identified with this issue.Device labeling, hemo-6373 v10 user manual, provides clear instruction that lv and ao are needed to successfully perform a "pullback" with statements such as, "the application provides an analysis algorithm for the lv/ao pullback waveform to find the aortic valve crossing point.The crossing point will be marked as a transition point in waveform review.The waveform segment to the left of the transition point will be labeled lv and the waveform segment to the right of the transition point will be labeled ao.By default, the transition point will be placed on the r-wave closest to the valve crossing transition point.The system will automatically deselect the beats to the left and right of the new transition point.These beats are usually aberrant due to the catheter handling in pullback.If the beats are clean enough to use, they may be reselected by clicking the proper r-wave space." two conclusions codes were used in this report: 77 (operational context caused or contributed to event) and 12 (design deficiency) since the problem initially occurred due to the operator's technique and because the software should not have allowed the user's mistake to cause an unhandled exception.(b)(4).

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 september 5, 2017, a customer reported to merge healthcare that a critical error occurred on the client pc during a procedure.Subsequently, the patient was moved to another lab after sedation had been initiated.Information obtained from the customer revealed that the site's cath lab 2 was shut down until the problem was resolved two (2) days later.With merge hemo not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient.However, the procedure was completed successfully once the patient was moved to a functioning lab onsite.(b)(4).

• 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: 6909900
• MDR Text Key: 89521123
• Report Number: 2183926-2017-00183
• 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
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.0.4 PATCH 1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2017
• 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