Avis De Sécurité sur BD Plastipak™ 50mL Luer Lok Syringes with Syringe Pumps

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par BD Medical.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Numéro de l'événement
    SN2014(02)
  • Date
    2014-02-11
  • Pays de l'événement
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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.

Device

  • Modèle / numéro de série
  • Description du dispositif
    BD Plastipak™ 50mL Luer Lok Syringes with Syringe Pumps
  • Manufacturer

Manufacturer