FDA Adverse Event Summary report: N

PRECISION DYNAMICS

MDR report key: 1766998 · Received June 24, 2010

Report

Report Number
1766998
Date Received
June 24, 2010
Date of Event
May 17, 2010
Report Date
June 24, 2010
Manufacturer
PRECISION DYNAMICS CORP.
Product Code
FZZ
Report Source
User Facility report
Reporter Location
IL, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

THE DAY SHIFT RN WAS PERFORMING HER MORNING ASSESSMENT AND NOTED THAT THE PATIENT WAS WEARING A BLUE ID BAND AND A RED ID BAND. IN OUR FACILITY, A BLUE BAND SIGNIFIES THAT THE PATIENT HAS A DO NOT RECUSSITATE (DNR) ORDER; A RED BAND IN OUR FACILITY SIGNIFIES ALLERGIES. THE NURSE RECALLS THAT IN THE HANDOFF SHIFT REPORT, SHE WAS NOT INFORMED BY THE NIGHT SHIFT RN THAT THE PATIENT WAS A DNR. THE PATIENT'S PLAN OF CARE ALSO DID NOT INDICATE A DNR WAS IN PLACE. THE RN REVIEWED THE MEDICAL RECORD ORDERS AND COULD NOT LOCATE A DNR ORDER; SHE ALSO SPOKE WITH THE PATIENT WHO STATED THAT HER WISHES WERE TO BE A FULL CODE. THE RN CALLED THE PATIENT'S PHYSICIAN AND LEARNED THAT THE PATIENT WAS A FULL CODE. NO DNR ORDER HAD EVER BEEN GIVEN FOR THIS PATIENT. THE RN REMOVED THE BLUE BAND AND NOTED THAT THE INFORMATION ON THE BLUE BAND WAS CORRECT--THE CORRECT PATIENT NAME AND DATE OF BIRTH. UPON FURTHER INVESTIGATION, IT WAS LEARNED THAT THE PATIENT ORIGNIALLY SOUGHT MEDICAL CARE AT ANOTHER FACILITY NEAR OURS. AT THAT FACILITY, THE BLUE BAND SIGNFIES ALLERGIES, WHICH THIS PATIENT DID HAVE. AT OUR FACILITY, A RED BAND SIGNIFIES ALLERGIES--BLUE AT OUR FACILITY MEANS DNR. THE INFORMATION ON THE BLUE BAND WAS CORRECT (NAME AND DATE OF BIRTH). THE ONLY DIFFERENCE BETWEEN THE INFORMATION ON THE BANDS WERE THE MEDICAL RECORD NUMBERS--THE MR NUMBER ON THE BLUE BAND WAS FROM THE OTHER FACILITY. AT OUR FACILITY, FOR THIS PATIENT, THE PROPER TWO UNIQUE IDENTIFIERS WERE THE NAME AND DATE OF BIRTH--STAFF AT OUR FACILITY FOLLOWED THEIR PROCESS CORRECTLY. OF PARTICULAR SIGNIFICANCE, THE PATIENT WAS BECOMING INCREASINGLY SHORT OF BREATH AND HAD INCREASED OXYGEN NEEDS. HAD THE NURSE NOT EXPLORED THE BLUE BAND, IT IS POSSIBLE THAT THE PATIENT'S MEDICAL CARE COULD HAVE BEEN DIFFERENT (E.G.: COMFORT MEASURES ONLY). THERE WERE MULTIPLE HUMAN FACTORS AT PLAY IN THIS EVENT AND WE CONSIDER THIS A "GOOD CATCH" OR NEAR MISS EVENT. WE CONTACTED THE OTHER FACILITY & INFORMED THEM OF THE EVENT. THEY ARE CHANGING THEIR PRACTICE OF USING BLUE BANDS TO SIGNIFY ALLERGIES & ARE CHANGING TO A PURPLE BAND FOR ALLERGIES. CURRENTLY, THERE IS NOT A STATE OR NATION-WIDE COLOR SYSTEM FOR ID BANDS. THE STATE OF ILLINOIS IS EXPLORING UNIFORM PATIENT ID BAND COLORS, BUT IT IS NOT IN PLACE YET AND THUS FAR IS NOT MANDATORY. WE HAVE NOT NOTIFIED THE ID BAND MANUFACTURER--THE DEVICE ITSELF DID NOT FAIL. RATHER, IT IS HOW THE DEVICES ARE USED BETWEEN DIFFERENT MEDICAL FACILITIES THAT IS THE CONCERN. PATIENTS NOT ONLY TRANSFER FROM HOSPITAL TO HOSPITAL, BUT ALSO FROM SKILLED NURSING FACILITY TO HOSPITAL, ETC.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE COLOR OF THE BAND AT ONE FACILITY HAD A DIFFERENT MEANING TO THE STAFF IN OUR FACILITY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PRECISION DYNAMICS PATIENT IDENTIFICATION BAND FZZ PRECISION DYNAMICS CORP. 518988113PDJ *

Patients

Seq Age Sex Outcome Treatment
1 80 YR