FDA.reportPublic FDA data

MAUDE MDR 6064714

MDR report key
6064714
Report number
2027454-2016-00001
Event key
0
Event type
3
Date of event
2016-09-28
Date received
2016-10-28
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#

Contact
MR. GEOFF GORHAM
Address
1225 CRESCENT GREEN DR., SUITE 300 CARY NC 27518 US
Phone
919-919-9198
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NAVICARE NURSE CALLNAVICARE NURSE CALLHILL-ROM CARYILQNNC 3.2.302R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-10-2801. O

Event Narratives#

N

Patient 1

THE PATIENT RECEIVED AN OVER DOSAGE OF HEPARIN. STAFF INTERVENED WITH ADDITIONAL MEDICINE AND THE PATIENT RECOVERED WITH NO ADVERSE OUTCOME. HEPARIN IS USED TO TREAT AND PREVENT BLOOD CLOTS IN THE VEINS, ARTERIES, OR LUNG. IT IS ALSO USED BEFORE SURGERY TO REDUCE THE RISK OF BLOOD CLOTS. BLEEDING IS THE CHIEF SIGN OF HEPARIN OVER DOSAGE. NOSEBLEEDS, BLOOD IN URINE OR TARRY STOOLS MAY BE NOTED AS THE FIRST SIGN OF BLEEDING. EASY BRUISING OR PETECHIAL FORMATIONS MAY PRECEDE FRANK BLEEDING. IMMEDIATE TREATMENT TO REDUCE HEPARIN'S EFFECT MUST BE ADMINISTERED. HILL-ROM'S INVESTIGATION DETERMINED THE PREVIOUS PATIENT'S WEIGHT WAS SENT FOR THE CURRENT PATIENT. ANALYSIS OF THE (B)(6) NURSE CALL'S LOG FILES FOUND THAT FOR THE ROOM IN QUESTION, THE BED WEIGHT WAS NOT ZEROED AND A NEW WEIGHT WAS NOT CAPTURED PRIOR TO THE PATIENT BEING ADMITTED INTO THE NNC SYSTEM. ADDITIONALLY, THE SITE'S CONFIGURATION WAS FOR THE BED DATA, WHICH INCLUDES THE WEIGHT, TO REFRESH IMMEDIATELY ON PATIENT ADMISSION. THIS CONFIGURATION SETTING WAS MODIFIED SO THAT THE BED DATA WILL NOT REFRESH ON ADMIT. THIS WAS TESTED AND CONFIRMED TO OPERATE AS DESIRED WITH THE CUSTOMER. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

D

Patient 1

HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING AN INCORRECT PATIENT WEIGHT WAS TRANSFERRED TO A PATIENT'S EMR AND BASED ON THAT WEIGHT, THE WRONG DOSAGE OF BLOOD THINNING MEDICATION WAS ADMINISTERED TO THE PATIENT. THE NURSE CALL SYSTEM WAS LOCATED AT THE ACCOUNT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).