MAUDE MDR 5719844

MDR report key
5719844
Report number
MW5062761
Event key
0
Event type
3
Date received
2016-06-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MEDICAL COMPUTER AND SOFTWAREMEDICAL COMPUTER AND SOFTWARENSX* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-06-090

Event Narratives#

D

Patient 1

(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.