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

Model Number MERGE HEMODYNAMICS 10.0.3

Device Problems Display or Visual Feedback Problem (1184); Device Displays Incorrect Message (2591); Output Problem (3005)

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

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

Troubleshooting from the customer determined that the error message of not ready was still present while performing a test cardiac output.Per the customer, they tried testing with different cables and leads.During troubleshooting with hemo support using the schiller test tool, thermo cardiac output (co) was dragged into chron log, dualtherm was selected from type drop down, and the injectant and distal fields were perfect.The ready button was active and allowed hemo support to select start, then it began to flash 'inject' indicating that the pb1000 and link assembly patient data module (pdm) were working correctly.This also indicated that there may be an issue with the y cable or bath probe.Further troubleshooting with hemo support using the tea cup test found no errors.During the tea cup test, no issues were noted.The customer was also provided with instructions on how to properly perform the co test.The potential impact to a patient has been reviewed and the risk level has been assessed as medium (non-serious injury).Per hemo-6373 merge hemo 10 user manual: page 146: constant cc.Read the insert that comes with the swan-ganz catheter and enter the constant cc.This number will vary based on the temperature range, volume injected, and the catheter itself.The value entered here must be correct.This value can be pre-set by opening a study and placing the appropriate constant cc in each type of thermo dilution catheter.The system will default to the last constant cc recorded for each catheter type by individual record station.Page 147-149: drag thermo co onto the chron log.Select the appropriate catheter from the category, equipment and type drop-down lists.Verify that the constant cc, temp to, temp from, and volume information is correct.If changes are needed, edit before continuing.Click start when ready to inject saline.Standby is displayed on the hemo monitor.The status will not change from standby as long as the system detects an out of range distal or injectant temperature.Note: additional status of the injectant and distal temperatures may appear indicating high, low, or off.When inject is displayed on the hemo monitor, inject saline.Thermo co display - inject prompt.The inject prompt will change to calculating and a graph of the cardiac output will appear.When complete, the co will be displayed on the hemo monitor and be recorded on the thermo co screen on the client pc.After the first co result has been captured and the value has been posted on both the hemo monitor and the thermo co screen, the user should allow the blood temperature to reach the reference temperature level.The reference temperature level is represented by the 0 level on the horizontal axis of the waveform.If the reference temperature level is not reached by the time the waveform becomes frozen, additional time should be allowed before the next injection is initiated.After sufficient time has passed for the temperature to return to the reference level, click start to begin the next co.This follows the standard clinical practice of allowing the reference temperature to stabilize before injecting the next volume of saline for subsequent co measurements.For accurate results, after the first output has been obtained follow this methodology for all other outputs.Once the measurement is completed on the hemo monitor pc, the heart rate and the cardiac output are posted.Note: only the calculated average can be changed, not the individual values.The user may clear the use in calculation check box to remove the co from the average.Note: the display of the flow volume calculations on the screen does not indicate that a subsequent injection and measurement should be initiated.A subsequent injection and measurement should be initiated only after the reference temperature level is reached.Note: the system will automatically wait until the reference temperature level is reached before any subsequent co measurements are performed.

Event Description

Merge hemodynamics displays, 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) 2018, the customer contact reported that an error message of not ready would appear when trying to inject a solution into the patient for the thermo cardiac output during a case.Subsequently, the patient was moved to another room during moderate sedation to finish the case.With merge hemo not functioning as expected, there is a potential for incorrect treatment that could cause harm to the patient.(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: 7725312
• MDR Text Key: 115682316
• Report Number: 2183926-2018-00064
• 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: health professional,user faci
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 06/28/2018

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
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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