EASYPUMP

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: 3 PUMPS COMPLETED THEIR INFUSION IN 24 HOURS INSTEAD OF THE EXPECTED 48 HOURS, WHILE THE OTHERS FUNCTIONED NORMALLY AND COMPLETED THEIR INFUSION IN 48 HOURS. NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER: (B)(4). INVESTIGATION RESULTS: FINAL CONTROL FLOW RATE REPORT OF AFFECTED BATCH 23F02GED91 WAS REVIEWED. FOR FINAL CONTROL FLOW RATE REPORT, THE AVERAGE FLOW RATE DEVIATION FROM THE NOMINAL FLOW RATE WAS BETWEEN 0.88% AND 9.86%. AS NO RETURNED SAMPLE WAS RECEIVED, FURTHER INVESTIGATION WAS NOT POSSIBLE. THERE ARE SOME POSSIBILITIES THAT CAN CAUSE THE SAMPLE TO EMPTY FASTER THAN NOMINAL TIME IN ACTUAL APPLICATION, SUCH AS ONE OR COMBINATION FACTORS OF MORE THAN ONE AS BELOW: FACTOR 1: TEMPERATURE: THE TEMPERATURE OF THE SURROUNDING WILL AFFECT THE FLOW RATE OF THE SAMPLE. FOR EVERY INCREASE OF 1°C, THE FLOW RATE OF THE SAMPLE WILL INCREASE APPROXIMATELY BY 3%. FOR EXAMPLE, IF THE FLOW RESTRICTOR OF THE PRODUCT REACHES THE TEMPERATURE OF 37°C, THE FLOW RATE OF THE SAMPLE WILL INCREASE BY APPROXIMATELY 18% WHICH MEANS THE FLOW RATE WILL INCREASE FROM 5ML/HR TO 5.9ML/HR. FACTOR 2: FOLDED OUTER SHELL (OUTER LAYER): FOLDED OUTER SHELL (OUTER LAYER) WILL ALSO ACT AS THE EXTERNAL PRESSURE TO ELASTOMERIC MEMBRANE AND INCREASE THE FLOW RATE OF THE PRODUCT. FACTOR 3: EXTERNAL PRESSURE: EXTERNAL PRESSURE SUCH AS SQUEEZING OR LAYING ON THE PUMP WILL INCREASE THE FLOW RATE WHICH CAUSES THE PUMP TO EMPTY EARLIER THAN THE NOMINAL TIME. SIMULATION OF EXTERNAL PRESSURE HAD BEEN CONDUCTED. THE FLOW RATE OF THE PRODUCT CAN INCREASE WHEN EXTERNAL FORCE IS APPLIED TO THE PUMP. HOWEVER, THIS EXTERNAL FORCE IS AGAINST THE INTENDED USE OF THE PRODUCT ACCORDING TO IFU. CONCLUSION: SINCE NO SAMPLE WAS RETURNED THEREFORE FURTHER INVESTIGATION WAS NOT POSSIBLE, HENCE WE CONSIDERED THIS COMPLAINT AS NOT CONFIRMED. REVIEWED THE BATCH MANUFACTURING RECORD (BMR) FOR BATCH 23F02GED91, THERE IS NO ABNORMALITY AND NO SUCH DEFECT DETECTED AT IN PROCESS AND FINAL CONTROL INSPECTION. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER: (B)(4). PREMARKET SUBMISSION # K081905.