inforMED
InjuryJSC

BBL SEPTICHECK

Received Sep 20, 1994 · Event occurred Aug 20, 1994

Report MW1003451 · MDR key 16269

Device

Generic name

Blood Culture Media

Catalog number

4343181

Lot number

051843KA

Product problems

  • Contamination

Patient

*

Narrative

Description of Event or Problem

DURING 8/20-9/10/94, NINE PTS WERE REPORTED AS HAVING POSITIVE BLOOD CULTURES FOR CANDIDA GUILLIERMONDI. TWO OF THESE PTS WERE REPORTED AS HAVING RHODOTORULA RUBRUM AS AN ADDITIONAL ISOLATE. THESE ISOLATES WERE SUSPECTED TO BE CONTAMINANTS DUE TO THE RARITY OF PAST ISOLATE OCCURRENCES, THE CLINICAL PRESENTATION OF THE PTS, AND THE RESULTS OF PREVIOUS AND FOLLOW UP BLOOD CULTURES ON THESE PTS. TWO OF THE NINE PTS WERE TREATED WITH ANTIFUNGAL AGENT(S) DUE TO THEIR IMMUNE STATUS. INQUIRIES TO THE BLOOD CULTURE MEDIA MFR REVEALED THAT R RUBRUM HAD BEEN REPORTED AS A PROBLEM CONTAMINANT FOR THE SLANTS. NO PREVIOUS REPORTS OF YEAST AS A BOTTLE CONTAMINANT WERE FOUND. INVESTIGATIVE CULTURES OF THE REMAINING SUSPECTED SLANTS (15) WERE NEGATIVE. CULTURES OF THE REMAINING BOTTLES (20) YIELDED ONE POSITIVE FOR YEAST, IDENTIFIED AS C GUILLIERMONDI. IN ALL CASES, THE PAIRED BLOOD CULTURE SET WAS NEGATIVE. FOR THE MAJORITY OF THE PTS, FOLLOW UP BLOOD CULTURES WERE DONE. ALL OF THESE WERE NEGATIVE. (NOTE: FOLLOW UP BLOOD CULTURES WERE DONE ON A DIFFERENT LOT NUMBER OF BOTTLES.) TREATMENT OF THE TWO PTS HAS BEEN DISCONTINUED. THE OTHER PTS HAVE NOT BEEN TREATED. CURRENTLY, ALL OF THESE PTS SHOW NO SIGN OF FUNGAL SEPSIS.