FDA Adverse Event Malfunction Summary report: N

HORIZON

MDR report key: 3250736 · Received May 15, 2013

Report

Report Number
3250736
Event Type
Malfunction
Date Received
May 15, 2013
Date of Event
April 25, 2013
Report Date
May 15, 2013
Manufacturer
MCKESSON TECHNOLOGIES, INC
Product Code
NVV
Product Problem
Yes
Report Source
User Facility report
Reporter Location
PA, US

Narratives

Description of Event or Problem · 1

HOSPITAL IDENTIFIED MEDICATIONS WERE INADVERTENTLY APPEARING ON PATIENTS' DISCHARGE MEDICATION RECONCILIATION PAPERWORK. THESE MEDICATIONS WERE NOT PRESCRIBED NOR INTENDED FOR THESE PATIENTS. REVIEW IDENTIFIED THIS WAS RELATED TO THE FACT THAT THE GENERIC ID WAS CHANGED ON A MEDICATION TEMPLATE IN HORIZON MEDS MANAGER (HMM). THE GENERIC ID ON THIS TEMPLATE IS NORMALLY -1. THIS CHANGE IN HMM ALSO CHANGED MED TABLES IN HORIZON CLINICALS. THIS ATTACHED A DIFFERENT MEDICATION TO THIS TEMPLATE. THIS TEMPLATE WAS CHANGED BACK TO THE CORRECT GENERIC ID IN HMM BUT THAT DID NOT UPDATE THE MEDICATION TABLE IN HORIZON CLINICALS. AS A RESULT, THE TEMPLATE REMAINED ATTACHED TO THE DRUG NORGESTREL-ETHINYL ESTRADIOL IN HORIZON CLINICALS TABLES. THE GENERIC ID WAS LATER CHANGED IN HMM TO MATCH THE MEDICATION LATUDA. THIS UPDATED THE HORIZON CLINICALS TABLES. AGAIN THE GENERIC ID WAS CHANGED IN HMM BACK TO -1 BUT DID NOT UPDATE THE HORIZON CLINICAL TABLES. AS A RESULT OF THE ABOVE MENTIONED CASE, 19 PATIENTS WERE AFFECTED. SIX WERE EITHER IDENTIFIED PRIOR TO DISCHARGE OR AT RECEIVING FACILITY UPON PATIENT TRANSFER. TEN WERE DISCHARGED HOME AND NEVER RECEIVED THE MEDICATION AT HOME. TWO WERE DISCHARGED HOME, NEVER RECEIVED THE MEDICATION AT HOME, BUT WERE SUBSEQUENTLY READMITTED AND ON READMISSION RECEIVED THE MEDICATION CAUSING NO HARM. ONE PATIENT WAS DISCHARGED TO A SENIOR NURSING FACILITY, RECEIVED THE MEDICATION AT THE SENIOR NURSING FACILITY, AND WAS SUBSEQUENTLY READMITTED WITH CHANGE IN MENTAL STATUS.======================MANUFACTURER RESPONSE FOR MEDICATION RECONCILIATION SOFTWARE (HMR), HMR (PER SITE REPORTER).======================HOSPITAL INFORMATION TECHNOLOGY LEADERSHIP CONTINUE TO WORK WITH VENDOR TO IDENTIFY ROOT CAUSE AND DATE OF SOFTWARE INTERFACE OCCURRENCE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ELECTRONIC MEDICATION RECONCILIATION SOFTWARE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
215989 HORIZON MEDICAL DEVICE MANAGEMENT SYSTEM NVV MCKESSON TECHNOLOGIES, INC * *

Patients

Seq Age Sex Outcome Treatment
1 *