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

Model Number MERGE HEMODYNAMICS 9.40.1

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

Patient Problem No Code Available (3191)

Event Date 06/30/2016

Event Type  malfunction  

Manufacturer Narrative

Merge's technical support provided guidance for the customer on how to change the analog out settings in the hemo application in order to change the data that is "slaved" out to a third party integrated ffr device.Information obtained from the customer revealed that the side stream module was also replaced that allegedly corrected the problem.Investigation activities are ongoing.(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 (b)(6) 2016, a customer reported to merge healthcare that the analog output was loose on the link assembly which prevented the user from completing a fractional flow reserve (ffr) procedure.Information obtained from the customer revealed that the patient had been sedated and was actively monitored.The site discontinued the procedure and instructed the patient to reschedule the procedure at another hospital.With merge hemo not presenting physiological data during treatment, there is a potential for a delay in care that may result in harm to the patient.(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 01aug2016.In the initial report's the narrative it was stated that a "side stream module" was replaced and corrected the customer's problem.However during documentation review activities, it was found that the replacement hardware shipped to the customer on 30jun2016 was a v2 4p link assembly (rma #(b)(4)).The faulty unit was returned to merge healthcare on 14jul2016 for evaluation.The results showed that the customer's reported problem, analog out problems, could not be duplicated.Additionally, the unit underwent testing and passed.For this reason, conclusion code 71 (no failure detected, device operated within specification) was used.The customer subsequently called in again about the same issue in the same cath lab 2 on (b)(6) 2016 (reference mdr #2183926-2016-00668).It was reported to merge technical support that the analog out settings were verified correct, the transducer was switched out and zeroed at the beginning of the procedure, and all connections were confirmed to be connected correctly.After the procedure, a portable unit was connected and the problem persisted.It was reported to merge technical support that the site corrected the issue and it was working consistently but the resolution was not divulged to merge healthcare.Merge healthcare attempted to send a mera tech onsite to troubleshoot further but the customer declined.Revised information contained in this supplemental report includes the following: evaluation codes: methods code: 10 actual device evaluated.Results code: 213 no failure detected.Conclusions code: 71 no failure detected, device operated within specification.Indication of additional manufacturer information and corrected data are 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: 5835905
• MDR Text Key: 50814016
• Report Number: 2183926-2016-00666
• 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: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 9.40.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2016
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1