Description of Event or Problem · 1
USER FACILITY ALLEGES THAT A PSEUDOMONAS PICKETTI (RALSTONIA PICKETTII) INFECTION DEVELOPED IN THREE (3) INFANTS THAT WERE TREATED IN THE INTENSIVE CARE UNIT OF THEIR FACILITY. THE HOSPITAL ALLEGES THAT THE R PICKETTII MAY HAVE ORIGINATED FROM 3ML SALINE UNIT DOSE 0.9% MANUFACTURED BY AUTOMATIC LIQUID PACKAGING, INC. CONTACT WAS INITIALLY ESTABLISHED BY AUTOMATIC LIQUID PACKAGING, INC WITH NEWBORN SUPERVISOR AT USER FACILITY ON MONDAY, APRIL 5, 1999. NEWBORN SUPERVISOR REPORTED THAT THEY PLACE NEWBORN INFANTS IN NEED OF INTENSIVE CARE ASSISTANCE IN THE ICU. THE INFANTS ARE INTUBATED AND SALINE IS ADDED TO THE ET TUBE, AS A LAVAGE, AND THEN HEALTH PROFESSIONALS SUCTION THE SECRETIONS. THE FIRST OF THE INFANTS WAS ADMITTED TO THIS AREA ON MARCH 19, 1999, THE SECOND ON MARCH 25, 1999 AND THE THIRD ON MARCH 26, 1999. ALL THREE BABIES WERE SUBSEQUENTLY DIAGNOSED WITH THE R PICKETTII INFECTION. NEWBORN SUPERVISOR STATED THE BABIES WERE ON ANTIBIOTICS AND ALL WERE STABLE. THE SAME LOT NUMBER OF 3ML 0.9% SODIUM CHLORIDE, 8E164, WAS USED WITH ALL THREE OF THE INFANTS. THIS LOT WAS SENT TO THE USER FACILITY LAB ON MARCH 29 OR 30TH. THE RESULTS OF THE CULTURE WERE OBTAINED ON THE AFTERNOON OF APRIL 1, 1999. ACCORDING TO NEWBORN SUPERVISOR THE RESULTS WERE R PICKETTII. IN MFR'S OPINION, ONE DAY MICROBIOLOGICAL TESTS ARE NOT ALWAYS AS ACCURATE AS A MORE LENGTHY ANALYSIS. IN ADDITION, THE OPPORTUNITY FOR TOUCH CONTAMINATION ALWAYS EXISTS IN A LABORATORY SETTING. FINALLY, MICROBIOLOGICAL ANALYSIS IS ALWAYS HIGHLY TECHNIQUE DEPENDENT. MFR CONTACTED NEWBORN SUPERVISOR ON MONDAY, APRIL 5, AND INSTRUCTED TO RETURN ANY UNOPENED PRODUCT OF THE ABOVE LOT NUMBER. BASED ON THE INVESTIGATION, THERE IS NO EVIDENCE TO INDICATE THAT AUTOMATIC LIQUID PACKAGING, INC 3ML UNIT DOSE SALINE IS THE CAUSE OF THE INFECTIONS. THE INVESTIGATION AT AUTOMATIC LIQUID PACKAGING, INC REVEALED THE FOLLOWING: 1. THE LOT OF PRODUCT THAT THE PATIENT USED, 8E164 WAS MANUFACTURED ON MAY 28, 1998. 2. A REVIEW OF THE BATCH RECORD FOR THIS LOT SHOWED NO DEVIATIONS TO PROCEDURES. 3. AUTOMATIC LIQUID PACKAGING, INC HAS NEVER HAD A COMPLAINT FROM THIS LOT OF PRODUCT, WHICH HAS BEEN MARKETED FOR 11 MONTHS. 4. A REVIEW OF THE BULK SOLUTION BIOBURDEN WAS UNDERTAKEN. THE SUBJECT LOT WAS MANUFACTURED ON 5/28/98. BIOBURDEN TESTING WAS PERFORMED ON ALL 48 PRODUCT LOTS FROM MAY THROUGH JUNE 1998. ALL RESULTS WERE WELL WITHIN ALERT LIMIT SPECIFICATIONS (10 CFU/100ML) FOR BIOBURDEN. SPECIFICALLY ON THE DAY OF MANUFACTURE OF THIS LOT OF PRODUCT THE BIOBURDEN WAS ZERO. 5. A STANDARD MEDIA FILL VALIDATION, WHICH ROUTINELY VALIDATES THE STERILE PROCESS WAS PERFORMED ON 5/22/98 THUS FURTHER DEMONSTRATING STERILE PROCESS EFFICACY. 6. THERE WERE NO EXCURSIONS FOR VIABLE AIR AND SURFACE MONITORING DURING MANUFACTURING AND DURING THE PERIOD ONE WEEK PRIOR TO AND ONE WEEK AFTER THE PRODUCT WAS MANUFACTURED. THE DATA ANALYZED WAS FROM THE DYNAMIC AIR AROUND THE FILL NOZZLE AREA WHERE THE ALERT LIMIT IS NMT 3 CFU/100FT. THE DATA ANALYZED FOR THE SURFACE MONITORING WAS ALSO FROM THE FILL NOZZLE AREA, WHERE THE ALERT LIMIT IS NMT 1 CFU/10 CM. 7. THE PRODUCT IS MANUFACTURED BY BLOW/FILL/SEAL TECHNOLOGY UTILIZING IN-LINE SUB-MICRON FILTRATION. THE PRODUCT IS FILTERED THROUGH A 0.1 MICRON FILTER, WHICH HAS BEEN VALIDATED AS RETENTIVE TO THIS SPECIFIC ORGANISM. 8. USER FACILITY RETURNED UNOPENED SAMPLES FROM LOT 8E164 FOR ADDITIONAL TESTING BY ALP. THESE SAMPLES AND ALP RETENTION SAMPLES FROM LOT 8E164 WERE STERILITY TESTED PER CURRENT REVISION OF UNITED STATES PHARMACOPEIA 14-DAY. THE RESULTS OF BOTH ANALYSES DEMONSTRATED THAT THE PRODUCT IN QUESTION IS STERILE IN ACCORDANCE WITH CURRENT USP REQUIREMENTS.