MAUDE Adverse Event Report: CERNER CORP. CERNER EMR; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

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

Patient Problem Insufficient Information (4580)

Event Type  No Answer Provided  

Event Description

Reporting 2 (two) errors with remdesivir labeling of the final product and total volume.Our institution uses cerner as our emr.It cannot recognize when a powder for reconstitution contains volume that needs removed from the final compounded iv bag.With remdesivir, the complex preparation involves reconstituting with 19 mls of sterile water for injection, removing 20 ml from a 100 ml ns bag, then adding 20 ml of the remdesivir solution to the final bag.We had two instances where the final product was labeled as a total volume of 80 ml rather than the 100ml that was actually in it.Ismp is a federally certified pt safety organization and an fda medwatch partner ismp, (b)(6).Submission id: (b)(6).

• Brand Name: CERNER EMR
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): CERNER CORP.
• MDR Report Key: 12280576
• MDR Text Key: 265558934
• Report Number: MW5103004
• Device Sequence Number: 1
• Product Code: JQP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1