MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE HEMO; HEMODYNAMIC RECORDING SYSTEM

Model Number 9.40.3

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189); Missing Value Reason (3192)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Type  Death  

Manufacturer Narrative

Merge requested that the site confirm the appropriate dosage rate with the manufacturer of integrilin.Based on the information provided by the manufacturer, both administration strategies are acceptable: administer a maximum constant drip rate above a specific patient weight, or administer increasing drip rates based on the patient's weight.The dosage is up to the ordering physician.The patient's death was not attributable to the use of the merge hemo device.Note: submission of this emdr was delayed due to significant delays experienced while working with fda to troubleshoot esg gateway issues.

Event Description

A health care provider contacted merge healthcare with a concern that the merge hemo hemodynamic recording system calculates a medication drip rate that does not account for a maximum drip rate for patients above a certain weight, for specific medications.The merge hemo system is intended to be used to document events that occur during a procedure in the cardiac catheterization lab.One feature that facilitates the documentation is the medication screen that can calculate and record medication dosage and drip rate information.The medication screen is intended to be used for documentation purposes only and is not intended to be used for determining the medication dosage and drip rate to be administered to the patient.As documented in the user guide: "the medication calculation functions are designed to augment the manual calculations of a competent, licensed professional who is already adequately trained in the administration of medications.The medication calculation functions are not intended to empower untrained or non-licensed individuals, nor replace the clinical training, judgment, interpretation, and/or intervention of a licensed professional.All medication calculations should be evaluated by a licensed professional prior to the administration of any medication." a few days later, the customer stated that prior to contacting merge, a patient weighing approximately (b)(6) had developed adverse reaction signs/symptoms (bleeding) in the cath lab and passed away after leaving the cath lab.The hospital initiated an investigation to determine the cause of death, which included a review of the documentation of the procedure that was recorded by hemo.Merge hemo had pre-populated the medication screen with a drip rate of 29ml/hr for documentation purposes.This site normally administers integrilin based on a maximum drip rate of 20ml/hr for any patient weighing more than 267lbs.The healthcare provider verified that the correct, intended integrilin dosage and drip rate of 20 ml/hr had in fact been administered to the patient per the request of the ordering physician, but the merge hemo documentation had not been updated: a) the iv pump had a safeguard maximum drip rate that does not allow it to exceed 20 ml/hr, and, b) the pyxis medication station recorded that the amount of integrilin medication retrieved corresponded to the amount required for the proper dosage.The site's review of the merge hemo documentation concluded that there had been a documentation error, but that no dosage error had occurred.The conclusion was that the patient's death was not attributable to the use of merge hemo.

• Brand Name: MERGE HEMO
• Type of Device: HEMODYNAMIC RECORDING SYSTEM
• 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: 5252552
• MDR Text Key: 32201140
• Report Number: 2183926-2015-00003
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 11/26/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: 9.40.3
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2015
• Initial Date FDA Received: 11/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2015
• 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
• Patient Weight: 181