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

Model Number MERGE HEMODYNAMICS 10.0.1

Device Problems Failure to Select Signal (1582); Use of Device Problem (1670)

Patient Problem Sudden Cardiac Death (2510)

Event Date 03/24/2016

Event Type  Injury  

Manufacturer Narrative

At this time, merge healthcare is unaware of the exact customer and their appropriate contact and whether their site will be submitting a medwatch to the fda concerning this event.When more information becomes available and the investigation is complete, a supplemental report will be submitted.

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 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 hemodynamics hemo monitor pc via the serial interface.All data can be shown and monitored on the hemodynamics hemo monitor pc.On (b)(6) 2016, a customer's representative reported to merge healthcare that a patient expired during a pacemaker procedure.Additional information provided revealed that the patient's spo2 started to drop and caused the patient to go into cardiac arrest.At that point, the patient had been declared brain dead by the medical staff.Information provided by the customer's representative also revealed that the patient's deteriorating state during the pacemaker procedure, went unnoticed by the medical staff for a period of time because the control room was unattended, the ekg alarm was not activated, nor did the site have the hemo speakers connected.The site admittedly states that this event was not caused by the merge hemo system but rather from the medical staff's inattentiveness.Due to the nature of the information reported by the customer, i.E.Patient death, merge healthcare elected to report this event even though there is no indication that the merge hemo product caused or contributed to the adverse event.(b)(4).

Manufacturer Narrative

Additional information obtained from the customer's representative revealed the following: no customer information will be divulged to merge healthcare.The customer conducted an internal investigation and it was determined that the event occurred solely from human error.Merge hemo was operating as expected.The customer will not be filing a medwatch for this event.Patient condition: it was initially reported by the customer's representative that the "patient was fairly healthy;" however, in follow-up communication with the representative, it was revealed that the patient was "in poor health." the customer has requested a visual cue be added to the software.Merge healthcare will be adding the following enhancements to a new release scheduled for rollout in the fall of 2016: add a client setting to set the threshold for the spo2 ecg tone change.Add a setting to enable ecg beep only when the spo2 threshold is passed.Have the spo2 display flash when the threshold is passed.Revised information contained in this supplement report includes the following: revised to "life threatening" since an actual death had not occurred at the time of the event.The patient's current state will not be divulged to merge healthcare.Revised to "serious injury" since an actual death had not occurred at the time of the event.The patient's current state will not be divulged to merge healthcare.

Event Description

New information obtained from the customer's representative revealed that a patient coded during a pacemaker procedure.The patient's spo2 dropped significantly and caused the patient to go into cardiac arrest.Once revived, the patient was declared brain dead by the medical staff.At that time, the patient was placed on life support; however, the patient's current state is unknown.

• 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; harland, WI 53029 ; 2629123570
• MDR Report Key: 5530770
• MDR Text Key: 41304386
• Report Number: 2183926-2016-00508
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 03/24/2016
• Initial Date FDA Received: 03/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2016
• 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
• Patient Outcome(s): Death; Life Threatening