CERNER MULTUM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-25 for CERNER MULTUM manufactured by Cerner.

Event Text Entries

[6018063] Pt was admitted with multiple allergies documented including dairy and milk. They were on a home medication of a dairy-free probiotic powder. Per our policy we do not continue home powders/liquids that we cannot identify (compared to a tablet with markings for identification). They initiated our formulary probiotic (floranex). After the first dose, the pt experienced symptoms that could be related to her allergy but it was not discovered until the second dose that the floranex chewable contains milk. There was no alert in our cpoe system ((b)(6)) to flag the provider or pharmacist of this allergy when the floranex was ordered/verified. In addition, when trying to investigate if floranex could have been the cause of the allergic reaction, the provider/ pharmacist went to (b)(6) which does not have this listed as a warning, precaution or contraindication (as it does with other food/drug allergies such as propofol with egg/soy). It is only listed under dosage forms which is not the first place the provider or pharmacist who typically search for this info. We are notifying both (b)(6) to suggestion changes to their data base. Until this is done, we are adding a custom alert in (b)(6) to notify the pharmacist. We wanted to share this info as it is vulnerability in a cpoe system that many hospitals use. It presents a safety concern as more pts come into hospitals on home "dietary supplements" that are not fda regulated and may not have safety checks such as allergy and interaction checking built into cpoe databases. I thought this might be a good item for the (b)(6) newsletter. Please let me know if you need any add'l info. (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5043431
MDR Report Key4884268
Date Received2015-06-25
Date of Report2015-04-02
Date Added to Maude2015-07-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCERNER MULTUM
Generic NameCPOE SYSTEM
Product CodeNSX
Date Received2015-06-25
Device Sequence No1
Device Event Key0
ManufacturerCERNER


Patients

Patient NumberTreatmentOutcomeDate
10 2015-06-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.