MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION DOSEEDGE PHARMACY WORKFLOW MANAGER; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Model Number DOSEEDGE SOFTWARE

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 03/01/2019

Event Type  malfunction  

Event Description

Error received for wrong route instead of wrong drug product.

• Brand Name: DOSEEDGE PHARMACY WORKFLOW MANAGER
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 8611497
• MDR Text Key: 145103442
• Report Number: 8611497
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2019

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: DOSEEDGE SOFTWARE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2019
• Date Report to Manufacturer: 05/15/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21900 DA