Description of Event or Problem · 1
RNS NOTED PCA INFUSIONS PUMPS WERE ALARMING WITH AN "OCCLUSION" NOTICE. AFTER A LONG INVESTIGATION, ONE OF THE RNS TALKED WITH ABBOTT/HOSPIRA AND WAS ADVISED THAT THERE WAS A PROBLEM WITH TWO SERIES OF LOT NUMBERS WHERE THERE WAS AN INSUFFICIENT AMOUNT OF SILICONE ON THE RUBBER STOPPERS USED IN THE GLASS PCA VIALS. THIS SOMEHOW DIMINISHED THE DRUG'S DELIVERY THROUGH THE PUMP CAUSING IT TO ALARM. AT LEAST TWO PTS ARE KNOWN TO HAVE NOT RECEIVED ADEQUATE ANALGESIA FOLLOWING MAJOR SURGERIES. THE LOTS IN QUESTION BEGIN WITH THE NUMBERS 16 OR 17. PRODUCT CONTAINING PRESERVATIVE IS NDC# 0074-6023-04. PRODUCT WITHOUT PRESERVATIVE IS NDC# 0074-2029-02. THE RPTR STATED TO THEIR KNOWLEDGE, ABBOTT DISCONTINUED THE PRESERVATIVE CONTAINING PRODUCT. THOUGH, THE HOSP HAD SOME OF EACH AND WAS USING THEM BY EARLIEST EXPIRATION DATE. THE FIRM WASN'T SPECIFIC ABOUT WHICH PRODUCT HAD THE SILICONE DEFICIENCY, THUS THE PHARMACY SEQUESTERED LOTS OF EACH BECAUSE BOTH HAD LOTS BEGINNING WITH "16". ABOUT 1,000 DOSES ARE REQUESTERED AT THIS TIME. FOR NCD# 0074-6023-04, THE PHARMACY HAS LOTS 16-105-DK, EXP DATE 4/1/2006, AND 16-147-DK, EXP DATE UNAVAILABLE AT TIME OF REPORT. FOR NDC# 0074-2029-02, THEY HAVE LOT 16-440-DK, EXP DATE 10/1/2005. SUBSEQUENTLY, USE OF LOT 18-371-DK, EXP DATE 12/1/2005 HAS BEEN OKAY. SAMPLES ARE AVAILABLE. WHAT'S TROUBLING IS ABBOTT/HOSPIRA KNEW ABOUT THE PROBLEM BUT DID NOT AND HAS NOT PUT OUT WORD TO ITS CUSTOMERS. EVEN THE LOCAL REP FAILED TO INFORM THE HOSP. YET, THE FIRM SENT THE HOSP'S BIOMED DEPT 31 OR 35 NEW PCA PUMPS.