Description of Event or Problem · 1
ON (B)(6) 2014, THE (B)(6) ROLLED OUT 800 NEW BBRAUN INFUSOMAT SPACE PUMPS AT THE (B)(6). THIS CULMINATED AN 18-MONTH LONG PROCUREMENT PROCESS AND WAS DONE WITH GREAT FANFARE. ALMOST IMMEDIATELY, IT WAS NOTED THAT THERE WERE PROBLEMS WITH THE TUBINGS THAT ACCOMPANIED THIS PUMP. SPECIFICALLY, MULTIPLE TUBINGS (SEE MODEL NUMBERS BELOW) WERE FOUND TO BE DEFECTIVE (E.G. LEAKING, SPIKE COMING OUT OF IV BAGS, TUBING COMING APART AT THE Y JUNCTIONS ETC..). THE FIRST INCIDENT WAS NOTED (B)(6) 2014 AND THE MOST RECENT ONE (B)(6) 2014 AND INVOLVED MULTIPLE DIFFERENT LOTS. THESE INCIDENTS HAPPENED ALL OVER THE HOSPITAL INCLUDING THE OPERATING ROOM, NICU, ER AND MEDICAL-SURGICAL FLOORS. IN ONE CASE, THE TUBING CAME APART AT THE Y JUNCTION OF A 3Y TUBING (BB363430, LOT# 0061354142) WHILE THE PT WAS RECEVING CYTOTOXIC MEDICATION. IN ANOTHER CASE INVOLVING BLOOD TUBING, THE LEAKING OCCURRED AT THE BOTTOM OF THE BLOOD FILTER. THE NURSE NOTED THAT THE NORMAL SALINE TO PRIME THE TUBING (MODEL BB363419) WAS POURING OUT OF THE FILTER ALL OVER THE FLOOR (FORTUNATELY THE BAG OF BLOOD WAS NOT YET ATTACHED) ON (B)(6) 2014. IN ONE INCIDENT, THE VENT CAME OFF THE TOP OF THE DRIP CHAMBER AND PROFOFOL BEGAN LEAKING ONTO THE FLOOR (04/09/2014; 363420, LOT# NA). IN THE MOST SERIOUS INCIDENT, AIR WAS FOUND BEING SUCKED INTO THE TUBING BETWEEN THE Y SITE AND THE BACK CHECK VALVE (BELOW THE PUMP; 04/24/2014; BB363430, LOT# NA). AS A RESULT, AIR COULD HAVE ENTERED INTO THE PT IF THE NURSE HAD NOT INTERVENED IMMEDIATELY. A TOTAL OF 17 INCIDENTS HAVE BEEN REPORTED IN 25 DAYS. AN EXCEL SPREADSHEET HAS BEEN ATTACHED TO THIS DOCUMENT TO OUTLINE PROBLEMS. THEY INVOLVE MODELS: 363421, 363430, 363419, 490032, 490036, 490041, AND 14 DIFFERENT LOTS. PHOTOS AND VIDEO ARE AVAILABLE TO DOCUMENT THE FINDINGS AND MANY OF THE DEFECTIVE TUBINGS HAVE BEEN COLLECTED AND RETURNED TO BBRAUN. AS AN INSTITUTION, WE HAVE REPLACED SIX DEFECTIVE LOTS 0061345766, 0061341773, 0061341773, 0061354142, 0061349780, 0061347778, AND 0061347776 ON ALL NURSING CARTS WITH NEW LOTS. ALL BBRAUN PUMPS HAVE BEEN REMOVED FROM THE ONCOLOGY TREATMENT CENTER AND REPLACED WITH THE OLD MODEL AND OLD TUBINGS DUE TO FEAR OF A CYTOTOXIC SPILL OR AEROSOLIZATION OF DRUG. TO DATE, NO PT HARM HAS BEEN NOTED BUT THE POTENTIAL IS CLEARLY VERY HIGH, AND INCLUDED POTENTIALLY FATAL VENOUS AIR EMBOLISM. OUR MATERIALS DISTRIBUTOR, (B)(4), HAS BEEN HELPFUL IN PROVIDING NEW TUBING LOTS WHEN THE "BAD" LOTS WERE QUARANTINED FROM USE. THE HEALTH (B)(6) RESPONSE IS PENDING. BBRAUN IS CONDUCTING AN INTERNAL INVESTIGATION. RESULTS HAVE NOT YET BEEN MADE AVAILABLE. THEY HAVE NOT RECALLED THE AFFECTED LOTS AS OF 05/05/2014. IT IS NOT KNOWN IF THEY HAVE FILED A MANDATORY DEVICE PROBLEM REPORT. EVENT: 2Y TUBING COMING APART AT Y SITE JUNCTION. REFERENCE NUMBERS: MW5036083, MW5036084, MW5036086, MW5036087, MW5036088, MW5036089, MW5036090, MW5036091, MW5036092, MW5036093, MW5036094, MW5036095, MW5036096, MW5036097, MW5036098, MW5036099.