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

Model Number MERGE HEMODYNAMICS 10.0.1

Device Problems Failure to Zero (1683); Device Operational Issue (2914)

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

Event Date 07/15/2016

Event Type  malfunction  

Manufacturer Narrative

Communication between merge healthcare and the customer revealed that the site does not routinely zero channel 3 and is likely that the ffr action editor was set incorrectly.It was also noted that the third party transducer was subsequently replaced.Hemo 10 user manual, addresses the potential for such an occurrence by statements such as, "in order to calculate ffr, the blood pressure proximal to a lesion must also be measured.A standard pressure transducer device is required.The standard pressure transducer used in the cardiac catheterization laboratory converts a column of fluid (pressure of the patients' arterial or venous system) into an electronic signal using a strain gauge that is then displayed on the hemodynamic monitor.The transducer should be zeroed at the beginning of every study as a precaution whenever a pressure displayed on the screen is suspect, or any time a new transducer is connected to the hemodynamic system.".

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 july 15, 2016, a customer reported to merge healthcare that integrated ffr (fractional flow reserve) would not equalize during a procedure.This resulted in a 15 minute delay.With merge hemo not capturing physiological data, there is a potential for incorrect treatment that results in harm to the patient.However, the customer reported that the procedure was completed successfully using a third party ffr device.(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: michael diedrick ; 900 walnut ridge drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5875977
• MDR Text Key: 52443163
• Report Number: 2183926-2016-00686
• 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: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.0.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2015
• 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