MEDICAL COMPUTER AND SOFTWARE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-09 for MEDICAL COMPUTER AND SOFTWARE manufactured by .

Event Text Entries

[47250328] (b)(4). Pt was admitted to our hospital on xx/xx/2016 for induction therapy for newly diagnosed secondary acute leukemia. She was still in house on xx/xx/2016. Our computer system is set so that all medications will auto-discontinue after 30 days. Among other issues, she was poorly controlled hypertension and was taking multiple antihypertensives. One of these is clonidine 0. 3 mg tid. On xx/xx/2016, the clonidine was discontinued and not reordered. She also was taking amlodipine 10 mg daily, which appears to also have been discontinued at the same time. Pt's blood pressure was elevated overnight starting approx 12 hours after clonidine stopped (up to 185 sbp). Unclear if providers or rn's realized clonidine and amlodipine were stopped. Clonidine restarted about 24 hours after stopped. Amlodipine not restarted but nifedipine sustained released started also about 24 hours after the amlodipine was stopped. Pt did develop bilateral scleral hemorrhages during this time frame - potentially from the hypertension. Her platelet count is approximately 50 at this time. We are struggling with this automatic state date - this is a new functionality for us. We integrated into a larger health care system in xxx 2015 - using the same ehr platform. We did not have a automatic stop date prior to the integration so are not really looking for this info - pharmacists don't use the functionality where the list of "to be expiring" medications show up. We would like to not have the 30 days stop date but get pushback from corporate compliance due to their interpretation of the cms 482. 25 (b)(5). From what we can tell, both (b)(4) are not in favor of automatic stop dates. We would love some advice from you on this matter or you bring it to a larger forum of discussion. Medication not administered to or used by the pt.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5062761
MDR Report Key5719844
Date Received2016-06-09
Date of Report2016-04-12
Date Added to Maude2016-06-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEDICAL COMPUTER AND SOFTWARE
Generic NameMEDICAL COMPUTER AND SOFTWARE
Product CodeNSX
Date Received2016-06-09
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2016-06-09

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