Syringe pumps are infusion assist devices commonly used in the clinic, which are mainly used for the precise infusion of certain particular drugs or high-risk drugs, and can be used to maintain a certain index value of a patient to be constant or used for continuous administration of drugs in order to achieve a better effect of administration. The devices create an advantageous condition for administration to first-aid patients, critically ill patients, particular patients and children, and improve the efficiency of medical personnel. However, it should be paid attention to that such a product will directly influence the administration safety and efficacy for the patients, if an abnormal control of the infusion flow rate occurs.
From 2002 to the end of 2010, National Center for ADR Monitoring, China had received 575 Reports on Suspicious Adverse Event of Medical Device relating to infusion pumps and syringe pumps in total, in which 216 reports are related to syringe pumps. These adverse events mainly include: abnormal control of the infusion flow rate, failing to pump medical fluids, system halt, leakage of infusion lines, and so on. Among these, there are 216 reports that show an abnormal infusion flow rate, in which 61 reports are related to syringe pumps (accounting for 28% of the total reports about syringe pumps).
A too fast infusion rate may cause an overdose and thus a toxicity occurrence, while a too slow infusion rate may cause an excessively small drug dose which is short of the therapeutic effect. Inaccurate control of the syringe pump rate may be associated with the software and the type, performance, etc. of related consumables (infusion lines and syringes) used. Another very important reason may be that the monitor system designed for the syringe pump is inadequate, such that the accuracy of the infusion flow rate cannot be ensured. A commercially available syringe pump generally has an electronic device for detecting the operating condition of a motor at a trailing end of the motor. However, as operation of the motor requires driving running of a injection pushrod by drive threads of a reducer and the reducer output shaft, which undergoes a series of motion conversion, a normal operation of the motor cannot fully ensure either a normal operation of the injection pushrod or the accuracy of administration, and thus there still exist potential safety risks.
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