Description of Event or Problem · 1
DEPT OF HEALTH IDENTIFIED CASES OF BURKHOLDERIA CEPACIA IN THREE (3) PEDIATRIC ICUS AT MED CTR. TWO (2) PTS DIED. TESTS CONDUCTED BY DEPT OF HEALTH ON SIX (6) PTS INDICATE THE LIKELIHOOD OF A COMMON SOURCE OUTBREAK, WHICH IS CURRENTLY A NELLCOR SUBLINGUAL CARBON DIOXIDE SENSOR. MED CTR WAS CONDUCTING A NON-FDA REGULATED STUDY WITH THIS MEDICAL DEVICE TO DETERMINE IF THE MEASUREMENT OF SUBLINGUAL CARBON DIOXIDE IS AN ACCURATE AND RELIABLE MEASUREMENT OF END-ORGAN PERFUSION IN CRITICALLY ILL PEDIATRIC PTS. THE HOSP REPORTED TO DEPT OF HEALTH THAT LUNG FLUID SAMPLES FROM THE TEN (10) PTS HAD TESTED POSITIVE FOR BURKHOLDERIA CEPACIA (FORMERLY PSEUDOMONAS CEPACIA), A GRAM NEGATIVE ROD, AND THE ORGANISM MAY HAVE BEEN INVOLVED IN TWO DEATHS. IT SHOULD BE NOTED THAT B. CEPACIA IS NORMALLY FOUND IN MOIST SOIL NEAR PLANT ROOTS AND IS NATURALLY RESISTANT TO MANY ANTIBIOTICS. THE HOSP HAS BEEN CONDUCTING THEIR OWN INVESTIGATION AND HAS ISOLATED B. CEPACIA IN THE BUFFERED SALINE SOLUTION OF AT LEAST ONE OF THE SUBLINGUAL CARBON DIOXIDE SENSORS. AN FDA/DEPT OF HEALTH INVESTIGATION IS ON-GOING. PT RECORDS HAVE BEEN REQUESTED AND SAMPLES OF THE SENSORS HAVE BEEN COLLECTED FOR ANALYSIS. MEDICAL CENTER STATED THAT NELLCOR HAS BEEN NOTIFIED.