MAUDE Adverse Event Report: MONARCH MEDICAL TECHNOLOGIES ENDOTOOL IV

Model Number IV 1.8.0 -1.10.1

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

Method 1 was removed from the most-recently cleared version of endotool iv.Monarch has notified all customers whose parameters include the use of method 1 of this issue, reminding them to always have the basal transition dosing recommendation verified by a physician prior to administering the dose.A tip card has also been provided with this information.To eliminate the risk of this issue recurring, monarch is requesting that customers upgrade to the newest software version of the endotool iv (b)(4) application, which only uses method 0 to calculate tdd.Customers who cannot upgrade soon will be offered a parameter adjustment, switching from use of method 1 to method 0 in their application.

Event Description

Monarch medical technologies has received complaints from customers that the basal transition dosing recommendation calculated by endotool iv 1.8.0 - 1.10.1 applications was higher than expected.None of the reported cases resulted in patient harm, as the bedside clinician was able to easily recognize the dose as being too high.Investigation concluded that one of the methods used for the tdd (total daily dose) calculation can result in an elevated basal transition dosing recommendation.The reporting customers each had "method 1" in use when they received elevated basal transition dosing recommendations from the application.Due to recurrence of this incident, we initiated an internal review of cases and found that the tdd method 1 was the cause of high transition recommendation in the prior cases, resulting in monarch the filing a 30 day mdr for this issue.This has been corrected in the next version of the software.Customers have been instructed to select a different tdd method in the affected versions of the software until they are able to upgrade to the new version.

• Brand Name: ENDOTOOL IV
• Type of Device: ENDOTOOL IV
• Manufacturer (Section D): MONARCH MEDICAL TECHNOLOGIES; 4400 stuart andrew blvd.; suite n; charlotte, nc
• Manufacturer (Section G): MONARCH MEDICAL TECHNOLOGIES; 4400 stuart andrew blvd.; suite n; charlotte, nc
• Manufacturer Contact: brian johnson ; 4400 stuart andrew blvd.; suite n.; charlotte, nc ; 5249660
• MDR Report Key: 9980931
• MDR Text Key: 196676826
• Report Number: 3009864844-2020-90002
• Device Sequence Number: 1
• Product Code: NDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IV 1.8.0 -1.10.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other