BD Plastipak™ 50mL Luer Lok Syringes with Syringe Pumps 에 대한 현장 안전성 서한

Field Safety Notice

SN2014(02)

2014-02-11

Ireland

HPRA

http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/bd-plastipak-50ml-luer-lok-syringes-with-syringe-pumps&id=5079f825-9782-6eee-9b55-ff00008c97d0

Bd has received complaints concerning an increase in the occurrence of occlusion alarms with the bd plastipak™ 50ml luer lok syringes. the root cause has been determined to be increased plunger rod forces primarily due to the interaction between the syringe barrel and the rubber stopper.  this issue only occurs when bd plastipak™ 50ml luer lok syringes are used in combination with syringe pumps. there is a risk of delay or interruption to treatment when these syringes are used in power-driven syringe pumps. there is no clinical concern when the syringe is used manually for all applications.  users may continue to experience unexpected occlusion alarms if using the current syringes in syringe pumps.

In April 2013, BD initially recommended a change in the settings of the syringe pumps (Field Safety Notification, 8th April 2013, MSS-13-191-FA). After continued complaints were received, an investigation revealed that it was not technically feasible to change the pump settings on some types of syringe pumps. To BD’s knowledge none of the pump companies made adjustments to software, thus clinicians were still experiencing increased occlusion alarming.  BD issued an updated Field Safety Notification, January 2014, MSS_13_277_FA informing users of their decision to review and modify the manufacturing process with a goal to reduce the plunger rod forces back to what is expected by the existing syringe pump programmes. BD has been able to reduce the plunger forces on the BD Plastipak™ 50mL Luer Lok Syringe back to a level that should reduce or eliminate the triggering of occlusion alarms when used in syringe pumps.  BD are now requesting users to disregard their previous notification of April 2013, which required users to make contact with their Bio-Medical Engineering Department to assess the pump and syringe and to re-programme the syringe pump.  BD has modified the design to lower plunger forces. The new design BD Plastipak™ 50mL Luer Lok Syringes, catalogue number 300865 will be available from the 10th February 2014. The other affected catalogue numbers will follow in the coming weeks.  Stock of the new design (with lower plunger forces) can be identified by an ‘N’ preceding the product code for example: N Ref 300865.  This safety notice only applies to the BD Plastipak™ 50mL Luer Lok Syringes when used in combination with syringe pumps. There is no clinical concern when the syringe is used manually for all applications.