MAUDE Adverse Event Report: RX30 VERSION 3.7.0.; PHARMACY SOFTWARE SYSTEM

Model Number BUILD 17230

Device Problems Application Program Problem (2880); Patient Data Problem (3197)

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

Event Date 09/08/2017

Event Type  malfunction  

Event Description

A staff pharmacist, during the verification process, noticed the patient on two different types of benzodiazepines.A therapeutic duplication warning did not flash as it should have.There was no patient harm as a result.Manufacturer response for pharmacy software system, version 3.7.0.(per site reporter): hospital leadership are currently working with them to determine the cause of the issue.

• Brand Name: VERSION 3.7.0.
• Type of Device: PHARMACY SOFTWARE SYSTEM
• Manufacturer (Section D): RX30; 788 montgomery avenue; ocoee FL 34761
• MDR Report Key: 6900894
• MDR Text Key: 87639107
• Report Number: 6900894
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/13/2017

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?: Yes
• Device Operator: No Information
• Device Model Number: BUILD 17230
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2017
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR