Graseby Syringe Drivers (MS16A & MS26) 에 대한 현장 안전성 서한

Field Safety Notice

SN2014(22)

2014-04-30

Ireland

HPRA

http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/graseby-syringe-drivers-(ms16a-ms26).-priority-2-warning.-caution-in-use&id=48cef925-9782-6eee-9b55-ff00008c97d0

The irish medicines board (imb) has recently received a number of incident reports from the irish market in relation to graseby syringe drivers (ms16a and ms26).  the incidents include the following:-  • pump stopped infusing  • medication infused too fast (over-infusion)  • medication infused too slow (under-infusion)  the imb wishes to advise users to use these devices with caution.  the imb also wishes to advise users that these devices are being discontinued from july 2014.  smiths medical has advised the imb that service and repair support will continue to be provided for a minimum period of 5 years; subject to smiths medical’s ability to source parts and components.

The IMB advises users:  (1) Graseby syringe drivers MS16A and MS26 should be used with caution. The IMB wishes to remind users of the following:-  a. These devices do not use standard measuring units. The MS16A is calibrated in milimeters (mm) per hour and the MS26 is calibrated in mm per 24 hour  b. The two models MS16A and MS26 are visually similar and care is needed to ensure the correct infusion rate is set  c. These devices lack a stop button. The devices can only be stopped by moving the rate switch to 00 or taking out the battery  d. The rate can be changed while the devices are in operation  e. There is no protection against misconnection of the syringe, air entrapment or siphoning. To help prevent tampering of the syringe or the syringe driver, lock boxes are available for use with these devices  f. The occlusion response characteristics of the device are very poor  g. The device does not retain a record of operation and cannot be interrogated  h. A ‘prime’ button provides maximum infusion rate when depressed. There is no limitation on the number of times this may be activated nor a record of activation  (2) Ensure that devices are repaired and maintained appropriately. The manufacturer advises that these devices have a minimum life expectancy of 5 years from date of sale. This is dependant upon the devices being serviced and maintained in accordance with the recommended instructions defined within the Instruction Manuals provided with the device. Failure to maintain the product regularly and effectively can shorten the lifetime of the device and in some instances can result in premature failure of the device. The warranty on these devices is 1 year.  (3) Due to the discontinuation of these devices from July 2014, the IMB wishes to remind those users who seek an alternative device to consider the following safety features when purchasing syringe drivers:-  a. Rate settings in millilitres (ml) per hour  b. Mechanisms to stop infusion if the syringe is not properly and securely fitted  c. Alarms that activate if the syringe is removed before the infusion is stopped  d. Lock-box covers and/or lock out controlled by password  e. Provision of internal log memory to record all pump events  Note: This is not an exhaustive list.  Further information may be obtained from the following IMB Safety Notices:  - IMB Safety Notice SN2006(03) The Procurement and Commissioning of Medical Equipment for Hospitals  - IMB Safety Notice SN2003(09) Equipment Management: Some Basic Principles of Equipment Management  - IMB Safety Notice SN2003(08) Equipment Management: Guidance for the Maintenance and Timely Replacement of Medical Equipment  (4) Forward this IMB Safety Notice to all those within your organisation that need to be aware of this information. Please also pass this Safety Notice on to any end users or organisations where these devices may have been distributed.