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

Model Number MERGE HEMODYNAMICS 10.0.1

Device Problem Computer Software Problem (1112)

Patient Problem Myocardial Infarction (1969)

Event Date 03/08/2016

Event Type  malfunction  

Manufacturer Narrative

Remote diagnostic testing was performed on the customer's hemo software, and sfc (system file checker) found corrupt windows files that could not be repaired as well as adobe errors.These have been attributed to the windows speech recognition feature.The customer was sent a thumb drive containing merge installer so the hemo client could be re-imaged.On 3/17/2016, the client computer was re-imaged.Subsequent remote diagnostic testing did not find any of the pre-existing warnings or errors.However, the customer was asked to complete more test studies using domain log-ons since the issue was intermittent to ensure the issue has been fixed.The problem is currently under investigation ((b)(4)).A follow-up report will be submitted with the results of the investigation when it is complete.

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 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 hemodynamics hemo monitor pc via the serial interface.All data can be shown and monitored on the hemodynamics hemo monitor pc.On (b)(6) 2016, a customer reported to merge healthcare that the hemo application froze during an emergent intervention case for a patient with myocardial infarction resulting in the procedure being delayed 5-7 minutes.The patient came from the er, was intubated, on a respirator, and the bp was 65.It was further reported that the patient's waveforms were displayed; however, there was no capability to measure or sample pressures.The medical staff used an impella catheter by which the patient's pressures could be measured and to provide partial circulatory support for the patient.The customer further reported that the ultimate outcome of the patient's condition was currently unknown.With merge hemo not presenting physiological data during treatment, there is a potential for a delay in care that results in harm to the patient.However, it was indicated that the heart catheterization procedure was completed successfully by means of using the impella catheter.(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 08apr2016.An internal investigation conducted by merge healthcare ((b)(4)) found that this issue is most likely related to recall 2183926-02/15/2016-041-c, z-1091-2017, in which the incorrect boot up sequence of the hemo monitor and client pc causes a connection issue between the two units.If the hemo monitor pc is powered on prior to the client pc, there is a potential that the hemo monitor pc will not recognize the second network card in the client pc.The proper order to start the system would be to start the client pc and log into windows or the hemodynamics application.After the client pc is running, the user should start the hemo monitor pc.Once the hemo monitor software is running, the user should see the record station toolbar active (not gray).This is an indication that the communication between the two pc's is functioning correctly.Should the record station toolbar become gray, the user should check the network cable between the two pc's.If the connection is correct, the user should restart the hemo monitor pc.Use of this product while communication is disconnected between the client pc and the hemo monitor pc will result in the user not being able to record pressures, start nibp, capture reference ecg, record thermo co, or use other physio controls.This could result in a delay in patient care.This problem has been addressed ((b)(4)) and will be corrected in a future release, merge hemo v10.2.Revised information contained in this supplemental report includes the following: g7: indication that this is follow-up report 1.H6: evaluation codes: methods code: 22 software evaluation.Results code: 628 communication problem.Conclusions code: 12 design deficiency.H7: indication that the reported issue is related to a recall.H10: indication of additional manufacturer information is contained in this follow-up report.

• 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: 5562184
• MDR Text Key: 42155114
• Report Number: 2183926-2016-00534
• 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: user facility
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.0.1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2016
• Initial Date FDA Received: 04/08/2016
• Supplement Dates Manufacturer Received: 04/16/2018
• Supplement Dates FDA Received: 06/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1091-2017
• Patient Sequence Number: 1
• Treatment: IMPELLA CATHETER; IMPELLA CATHETER
• Patient Outcome(s): Life Threatening
• Patient Age: 79 YR