Description of Event or Problem · 0
BBRAUN PRODUCT 8713051U, INFUSOMAT SPACE IV PUMP SERIAL NUMBER (B)(4) (DEVICE) EXHIBITED BOLUS BEHAVIOR (OVER INFUSION) OF CISATRACURIOM (NIMBEX) DRIP CAUSING PROFOUND HYPOTENSION IN CRITICALLY ILL ICU PATIENT. THIS INCIDENT WAS INVESTIGATED BY BIOMED AND BBRAUN MEDICAL INC. THE DATA RETRIEVED FROM THE DEVICE HAS SHOWN THAT IT WAS PROGRAMED TO INFUSE CISATRACURIUM (NIMBEX) DRIP, AND; THAT NIMBEX DRIP WAS INFUSED AT THE RATE OF 588 ML/HR INSTEAD OF 6.53 ML/HR, DELIVERING 85.42 ML OF NIMBEX IN APPROXIMATELY 9 MINUTES. THE PATIENT HAS SURVIVED BECAUSE 2 (TWO) REGISTERED NURSES AND A CRITICAL CARE PHYSICIAN WHO WERE JUST OUTSIDE OF THE PATIENT'S ROOM WHEN AIR-IN-THE-LINE ALARM WENT OFF, RESPONDED AND TOOK IMMEDIATE ACTION TO SAVE THE PATIENT'S LIFE. BBRAUN MEDICAL INC. HAS SUGGESTED THAT THEIR DEVICE WAS ERRONEOUSLY PROGRAMMED BY A NURSE TO INFUSE NIMBEX AT THE RATE OF 588 ML/HR. PARTICULARLY, BBRAUN MEDICAL INC. HAS STATED: "WE ARE ABLE TO CONFIRM THAT THE PUMP PERFORMED THE INFUSION RATES THAT WERE ENTERED INTO THE DEVICE BY THE NURSE. BECAUSE THE LOG SHOWS THAT THE PUMP PERFORMED AS PROGRAMMED, WE CANNOT ATTRIBUTE THE OVER INFUSION TO THE DEVICE." HOWEVER, THE BBRAUN MEDICAL'S SUGGESTION IS TOTALLY WITHOUT MERIT BECAUSE: AT OUR FACILITY, DUE TO PRE-PROGRAMMED HARD STOP ON EVERY BBRAUN IV PUMP, IT IS ABSOLUTELY IMPOSSIBLE FOR ANY NURSE TO PROGRAM ANY BBRAUN INFUSOMAT SPACE IV PUMP TO INFUSE ANYTHING INCLUDING NORMAL SALINE AT THE RATES EXCEEDING 500 ML/HR; AT OUR FACILITY, THE PARAMETERS FOR CISATRACURIUM (NIMBEX) INFUSION SUCH AS CONCENTRATION, VOLUME, AND THE MAXIMUM DOSE AND THE RATE OF INFUSION ARE PRE-PROGRAMMED. THE NURSES CAN ONLY INPUT THE PATIENT'S WEIGHT, AND EVEN IF THE PATIENT'S WEIGHT IS ENTERED INCORRECTLY, THE PRE-PROGRAMMED MAXIMUM DOSE/RATE WILL PREVENT ANY FURTHER PROGRAMMING AND OPERATION OF THE DEVICE; OUR FACILITY HAS A POLICY OF DOUBLE CHECK WHEN PROGRAMMING NIMBEX OR OTHER CRITICAL CARE INFUSIONS. IN THIS PARTICULAR CASE, THE PROGRAMMING WAS PERFORMED AND DOUBLE CHECKED BY 2 (TWO) REGISTERED NURSES. THE CORRECT MEDICATION (CISATRACURIUM), CORRECT CONCENTRATION OF 2 MG/ML, DOSE OF 2 MCG/KG/MIN, AND VOLUME OF 90 ML WERE PROGRAMMED BY 2 NURSES. THE DEVICE WAS DISPLAYING A CORRECT RATE OF 6.53 ML/HR, BUT WHEN INFUSION STARTED, THE DEVICE WAS ACTUALLY INFUSING AT THE RATE OF 588 ML/HR INSTEAD OF PROGRAMMED AND DISPLAYED 6.53ML/HR. BECAUSE THESE BBRAUN PUMPS ARE NOT SAFE FOR THE ICU PATIENTS, AND BECAUSE THE BBRAUN'S UNWILLINGNESS TO TAKE RESPONSIBILITY IS ABSOLUTELY UNACCEPTABLE AND DANGEROUS TO THE PATIENTS, WE STRONGLY BELIEF THAT THESE BBRAUN INFUSOMAT SPACE IV PUMPS PRODUCT 8713051U MUST BE RE-CALLED UNTIL THE CAUSE FOR OVER INFUSIONS/BOLUS BEHAVIORS IS DETERMINED AND ELIMINATED. FDA SAFETY REPORT ID# (B)(4).