Description of Event or Problem · 1
FACILITY EXPERIENCING PROBLEMS WITH LEAKING IV TUBING. FACILITY HAS BEEN IN CONTACT WITH MFR REGARDING THIS ISSUE, AND HAS SENT MULTIPLE SAMPLES BACK TO THE MFR FOR EVAL. NO PT INJURY HAS RESULTED FROM THE DEFECTIVE TUBING. HOWEVER THESE EVENTS HAVE CAUSED DELAYS FOR THE ANESTHESIA TEAM IN CRITICAL SITUATIONS. LETTER FROM MFR STATES, "THIS LETTER IS IN RESPONSE TO YOUR REPORT REGARDING IVAC ADMINISTRATION SETS REPORTED FOR "LEAKS AT ADAPTER TO PVC TUBING." THANK YOU FOR PROVIDING SAMPLES FOR EVAL BY OUR QUALITY ASSURANCE DEPARTMENT. THE RESULTS OF THE EVAL ARE AS FOLLOWS: ONE SET EACH FROM MODEL 59293E, LO NUMBER 802658, AND MODEL 59980E, LOT NUMBER 707676, WERE REC'D FOR ANALYSIS. THE SETS WERE PRESSURE LEAK TESTED AND WERE NOTED TO BE LEAKING AT THE ADAPTER TO PVC TUBING ENGAGEMENTS. FURTHER TESTING REVEALED THAT INSUFFICIENT SOLVENT HAD BEEN APPLIED TO THE ENGAGEMENTS DURING THE MFG PROCESS. OUR QUALITY ENGINEERS HAVE IMPLEMENTED CORRECTIVE ACTION TO ADDRESS THIS ISSUE. PRODUCTION PERSONNEL HAVE BEEN INFORMED OF YOUR REPORT ANS SUBSEQUENT EVAL OUTCOME, AND RE-TRAINING HAS BEN INSTITUTED. IN ADDITION, BOTH THE PRODUCT DESIGN AND THE ASSEMBLY PROCESS HAVE BEEN MODIFIED TO PREVENT THE LIKELIHOOD OF FUTURE OCCURRENCES. ALARIS WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS. WE HOPE THESE ACTIONS MEET YOUR EXPECTATIONS AND WE APOLOGIZE FOR ANY DISRUPTION THIS EVENT HAS CAUSED YOUR ORGANIZATION. EXCEPTIONAL PRODUCT RELIABILITY AND THE HIGHEST LEVEL OF CUSTOMER SATISFACTION ARE OUR PRIMARY GOALS". ANOTHER LETTER FROM THE MFR STATES, "THIS LETTER IS IN RESPONSE TO YOUR REPORT REGARDING TEH MODEL 72213N IVAC ADMINISTRATION SETS, LOT NUMBER 706402 AND 802416, REPORTED FOR "LEAKS." THANK YOU FOR PROVIDING SAMPLES FOR EVAL BY OUR QUALITY ASSURANCE DEPARTMENT. THE RESULTS OF THE EVAL ARE AS FOLLOWS: TWO SAMPLES, ONE FROM EACH LOT NUMBER WERE INITIALLY REC'D FOR ANALYSIS. THE SETS WERE PRESSURE LEAK TESTED AND WERE NOTED TO BE LEAKING AT THE DRIP CHAMBER TO PVC TUBING ENGAGEMENTS. FURTHER INVESTIGAION REVEALED INSUFFICIENT SOLVENT AT THE ENGAGEMENT. OUR QUALITY ENGINEERS HAVE IMPLEMENTED CORRECTIVE ACTION TO ADDRESS THIS ISSUE. PRODUCTION PERSONNEL HAVE BEEN INFORMED OF YOUR REPORT AND SUBSEQUENT EVAL OUTCOME, AND RETRAINING HAS BEEN INSTITUTED. IN ADDITION, BOTH THE PRODUCT DESIGN AND THE ASSEMBLY PROCESS HAVE BEEN MODIFIED TO PREVENT THE LIKELIHOOD OF FUTURE OCCURRENCES. ALARIS WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS. AT A LATER DATE AN ADDITION SET FROM MODEL 72213N, LOT NUMBER UNKNOWN, WAS REC'D. THE SAMPLE WAS PRIMED AND WAS NOTED TO BE LEAKING AT THE DRIP CHAMBER/TUBING ENGAGEMENT. FURTHER ANALYSIS REVEALED A MOLDING DEFECT AT THE BOTTOM OF THE DRIP CHAMBER. THE DRIP CHAMBER SUPPLIER HAS BEEN NOTIFIED AND THEY HAVE MODIFIED THEIR MOLDING PROCESS TO REDUCE THE LIKELIHOOD OF FUTURE OCCURRENCES. ALARIS WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS."