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

Model Number MERGE HEMODYNAMICS 10.0.3 PATCH 1

Device Problems Failure to Transmit Record (1521); Data Problem (3196)

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

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

The faulty hardware has not been received from the customer as of 14dec2016 for evaluation.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 an error occurred with the hemo thermo cardiac output.Information obtained from the customer revealed that the problem occurred during a cardiomems procedure (procedure to implant a heart failure monitoring device that transmits patient's pulmonary artery pressure to a medical site database).The user replaced the catheters, transducers, cables, and pdm (patient data module) while the patient was sedated and resulted in a 1.5 hour delay.It was reported that the procedure could not be cancelled or rescheduled because of implanting the device and the need to calibrate it before the patient left the medical facility.With merge hemo not presenting physiological data during treatment, there is a potential for delay in treatment that could result in harm to the patient.However, the customer confirmed that the procedure was completed successfully once all of the hardware was replaced.(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 18dec2016.During troubleshooting activities with merge technical support, the customer reported that the site used the provided test plug/simulator and it was determined that the cardiac output (co) was faulty.Merge technical support shipped the customer replacement hardware noted below to correct the issue.The potential impact to a patient has been reviewed and the risk level has been assessed as medium (non-serious injury).V2 4p nellcor nibp 2.X (pdm - patient data module, rma #(b)(4)) the replacement was shipped to the customer on 18nov2016.The faulty unit was sent to the manufacturer for evaluation and received by merge healthcare on 08dec2016.The manufacturer's evaluation results showed that the customer's reported problem, failing cardiac output, could not be duplicated.The unit underwent testing and passed and was then upgraded and re-certified for use.V2 4p link assembly (rma #(b)(4)) the replacement was shipped to the customer on 18nov2016.The faulty unit was returned to merge healthcare on 02dec2016 for evaluation.The results showed that the customer's reported problem, failing cardiac output, could not be duplicated.The unit underwent testing and passed and was returned to service stock.For this reason, conclusion code 71 (no failure detected, device operated within specification) was used.Device labeling, hemo-6373 v10 user manual, addresses the potential for such an occurrence in the troubleshooting section which states, "problem: thermodilution cardiac output display shows inaccurate data for temperature/no temperature, or erroneous constant swan values that affect hemodynamic calculations.Solution: refer to "thermo cardiac output" on page 379 for detailed explanation of correct catheter selection and the importance for the use of correct settings.Also see "thermo co template text item" on page 145 for proper practical use during the hemo application." no further actions are anticipated at this time due to the issue being readily apparent to the user, the non-serious impact to a patient, and the instructions provided in the user manual on steps to take if a thermo co output issue was to occur.Revised information contained in this supplemental report includes the following: g7 - indication that this is follow-up report 001.H6 - evaluation codes: methods code #1: 3345 simulated use testing (conducted by customer).Methods code #2: 10 actual device evaluated (conducted by merge healthcare).Results code #1: 3249 evaluation result (customer alleged failure).Results code #2: 213 no failure detected (merge healthcare's evaluation results).Conclusion code: 71 no failure detected, device operated within specification.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: 6184660
• MDR Text Key: 62679415
• Report Number: 2183926-2016-00820
• 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
• Type of Report: Initial,Followup
• Report Date: 11/18/2016

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 10.0.3 PATCH 1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/18/2016
• Supplement Dates Manufacturer Received: 12/08/2016
• Supplement Dates FDA Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ST. JUDE CARDIOMEMS; ST. JUDE CARDIOMEMS