MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE HEMODYNAMICS PROGRAMMABLE DIAGNOSTIC COMPUTER, PRODUCT CODE: DQK

Model Number MERGE HEMODYNAMICS 10.0.4 PATCH 1

Device Problems Failure to Transmit Record (1521); Device Issue (2379)

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

Event Date 07/19/2017

Event Type  malfunction  

Manufacturer Narrative

During troubleshooting efforts with the customer and merge technical support, the patient data module (pdm) was tested with the testplug and the pdm was able to capture pressures on all four ports. The customer reported that they would replace their cables. Merge healthcare is continuing to follow up with the customer for additional patient information and resolution of event. If further information is received from the customer, a supplemental report will be submitted. According to hemo-(b)(4), merge hemo 10 user manual, p. 58: channel 1 through 4 - allows the user to select a location label for recording invasive pressures. This includes setting up and selecting pressure labels to allow for common recordings to be captured. If a transducer or cable is not connected, the affected channel(s) will be grayed out. P. 368: problem: invasive pressure readings and waveforms are not displayed on the hemo monitor. Solution: possible solutions include proper connection of the transducer cable into the pdm for the necessary pressure channel, the transducer cable connection into the customer-supplied transducer, and the integrity of the air-free line to enable a measurement from the most distal catheter location to the hemo screen. Ensure the correct pressure channel is selected for display, and on the correct scale. Additionally, fluid such as saline or contrast at a connection point may compromise a secure fit or provide erroneous values for display. Consider replacing: 1. Transducer cable from pdm, 2. Customer-supplied transducer kit, or checking placement of stopcocks to 'open' or 'closed' as appropriate.

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. A customer reported to merge healthcare on (b)(6)2017, that during a procedure, all pressure channels were grayed out. The site did report that they were only able to get a mean pressure. As a result of the pressure channels being greyed out, the user stated that they could not perform the study correctly. No additional information from the customer was provided. With merge hemo not capturing physiological data, there is a potential for a delay in treatment and/or incorrect treatment that could cause harm to the patient. At this time there is no indication that any patient harm occurred. Reference complaint number (b)(4).

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER, PRODUCT CODE: DQK
• 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
• MDR Report Key: 6796523
• MDR Text Key: 83206916
• Report Number: 2183926-2017-00170
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: MERGE HEMODYNAMICS 10.0.4 PATCH 1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse