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

Model Number MERGE HEMODYNAMICS 10.0.4 PATCH 1

Device Problems Device Issue (2379); Device Operational Issue (2914)

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

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

To resolve the issue, per the customer contact, the cables were switched around and the hemo monitor started working and the case was completed successfully.Merge technical support shipped replacement hardware (rma #(b)(4)) to the customer.The faulty pb-1000 unit was returned to merge healthcare by the customer for evaluation, however has not yet been received.Therefore conclusion (#11) was selected as the investigation is not yet complete.The potential impact to a patient has been reviewed and the risk level has been assessed as medium (non-serious injury).Additionally, this event is typically recognized prior to the start of a case when the user is setting up equipment.The merge hemo user manual includes a guide on the communication between the pdm and the hemo monitor pc, equipment care guide, and tips on frequently asked questions.Per hemo-6373 merge hemo 10 user manual: (p.54) communication; record station: when a command is issued by touching or clicking an icon on the client pc, the hemo monitor pc responds.Physiologic monitoring is accomplished by these two computers joined via unique communication protocols.There are three icons on the bottom of the hemo monitor, left of the time display, that are displayed as visual indicators of system status.The patient name is displayed at the top of the screen and the day, date, and time are displayed at the bottom of the screen.(person) this icon appears to indicate communication between the hemo monitor pc and the patient data module (pdm).If there is a problem with any of the functions represented by the above three images, the icon color will switch to red.(p.363).Pdm: 1.Check the physical condition of the pdm and its cleanliness.2.Ensure that the calibration is current (according to the round sticker on bottom).If needed, order a replacement.Factory calibration is done before the unit is shipped.If the site requires the calibration of the unit to be checked, a transducer should be connected to a channel and 100 mmhg applied to the transducer with a mercury manometer.Ensure that it is within the ±1% tolerance that is allowed by the manufacturer.If the unit is outside of this specification, it should be returned.General: inspect overall physical condition of the system components, peripherals, and interconnecting cables.Perform any corrective actions required.(p.378).Question: why isn't the system showing any waveforms or numbers? answer: check for the green light on the pdm and ensure the link is up.Check to see if any cables are disconnected.

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.A merge hemo customer reported to hemo technical support on (b)(6) 2018, that during a case the people/person icon on the hemo screen started flashing red indicating a communication issue with the patient data module (pdm).The hemo monitor pc was rebooted once prior to the start of the case and once during the case while the patient was being actively monitored and sedated.Both invasive and non-invasive pressures were being monitored and a 3rd party monitoring device was not used while the hemo monitor was rebooted.There was no indication of patient harm as a result of this issue.However, with merge hemo being rebooted and not capturing physiological data, there is a potential for delay in treatment that could cause harm to the patient.(b)(4).

Manufacturer Narrative

The results of the pb1000 evaluation found a hardware failure.The vendor could not duplicate the customer's allegation of communication issues, however discovered a bad exhaust valve.The valve was replaced and the unit re-certified and passed testing.Revised information contained in this supplemental report includes the following: evaluation codes: methods code: 10 - testing of actual/suspected device.Results code: 174- material and/or chemical problem identified, 135- degradation problem identified.Conclusions code: 4307- cause traced to component failure.

• 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: 7513316
• MDR Text Key: 108618817
• Report Number: 2183926-2018-00038
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00842000100010
• UDI-Public: 842000100010
• 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: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 10.0.4 PATCH 1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1