MEDITECH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-10 for MEDITECH manufactured by Medical Information Technology, Inc..

Event Text Entries

[144945554] The physician order entry system (patient keeper) failed to script the order for rapaflo correctly into the hosp info system (meditech). When this occurs, the pharmacist must manually key the order into meditech. Pharmacist incorrectly selected rapamune instead of rapaflo after entering rap into meditech. Since rapaflo is non formulary rapamune was the search result and was selected by the pharmacist. No alert resulted because enabled warnings within meditech are limited to all of the medications being on formulary. The pharmacist and nurse were not familiar with rapaflo, and did not research the medication before choosing rapamune. The verification process failed at both the nursing and pharmacy levels. (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5086541
• MDR Report Key: 8600468
• Date Received: 2019-05-10
• Date of Report: 2019-05-10
• Date Added to Maude: 2019-05-10
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: MEDITECH
• Generic Name: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Product Code: MMH
• Date Received: 2019-05-10
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDICAL INFORMATION TECHNOLOGY, INC.

Device Sequence Number: 2

• Brand Name: PATIENT KEEPER
• Generic Name: MEDICAL DEVICE DATA SYSTEM
• Product Code: OUG
• Date Received: 2019-05-10
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: PATIENTKEEPER, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-05-10