FDA Adverse Event Injury Summary report: N

NAVICARE NURSE CALL

MDR report key: 6064714 · Received October 28, 2016

Report

Report Number
2027454-2016-00001
Event Type
Injury
Date Received
October 28, 2016
Date of Event
September 28, 2016
Report Date
September 28, 2016
Manufacturer
HILL-ROM CARY
Product Code
ILQ
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
OH, US
Reporter Occupation
HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 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.

Description of Event or Problem · 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).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
716502 NAVICARE NURSE CALL NAVICARE NURSE CALL ILQ HILL-ROM CARY NNC 3.2.302

Patients

Seq Age Sex Outcome Treatment
1 Other