MAUDE Adverse Event Report: UNKNOWN ELECTRONIC HEALTH RECORD SYSTEM

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

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

Event Type  Other  

Event Description

This is about the risk of using an outdated weight documented via an electronic health record system.A physician at our facility entered an order on a(b)(6) for a weight based dosed med.When the system recognizes the "mg/kg" unit, it tries to look for the latest weight in the system and auto calculates the final dose.The system displays this calculation and even the date/time the weight was taken.Unfortunately, there was no limit defined in the system as to how far back the system should look to find a weight, and the physician did not pay attention to the date of the weight.Subsequently, the system calculated an underdose and was accepted by the physician, the rn, but caught by the verifying pharmacist.Facilities with the electronic health record system feature of dose auto calculation of a weight based prescribed does should have a time limited as to how far back a previous weight should be used for calculations.Medication administered to or used by the pt: no.When and how was error discovered: subsequently, the system calculated an underdose and was accepted by the physician, then rn, but caught by the verifying pharmacist.Level of staff who discovered the error: pharmacist.Reporter's recommendations: facilities with the electronic health record system feature of dose auto calculation of a weight based prescribed dose should have a time limit as to how far back a previous weight should be used for calculations.Severity: error occurred; medication did not reach pt.(b)(6).

• Brand Name: ELECTRONIC HEALTH RECORD SYSTEM
• Type of Device: ELECTRONIC HEALTH RECORD SYSTEM
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 5728736
• MDR Text Key: 47598970
• Report Number: MW5062887
• Device Sequence Number: 1
• Product Code: JQP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2016

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: 06/14/2016
• Type of Device Usage: N
• Patient Sequence Number: 1