HORIZON *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-15 for HORIZON * manufactured by Mckesson Technologies, Inc.

Event Text Entries

[15013929] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3250736
MDR Report Key3250736
Date Received2013-05-15
Date of Report2013-05-15
Date of Event2013-04-25
Report Date2013-05-15
Date Reported to FDA2013-05-15
Date Reported to Mfgr2013-07-29
Date Added to Maude2013-07-29
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHORIZON
Generic NameMEDICAL DEVICE MANAGEMENT SYSTEM
Product CodeNVV
Date Received2013-05-15
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerMCKESSON TECHNOLOGIES, INC
Manufacturer AddressONE POST STREET SAN FRANCISCO CA 94104 US 94104


Patients

Patient NumberTreatmentOutcomeDate
10 2013-05-15

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