Events

Rappel de Sorin Perfusion System - S5/C5 Heart Lung Machine

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Cellplex Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-01283-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-12-05
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01283-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer, sorin group deutschland gmbh has received reports of some malfunctioning em1 model shaft encoders in the pumps. the encoder housing can be exposed to excessive traction resulting in the speed encoder becoming non-responsive and displaying an error message "shaft angle encoder fault". this fault results in the encoder code wheel coming in contact with the silicone detector cover and drawing out the silicon material from the detector housing. if the pump module has to be replaced and the perfusionist is not able to maintain the blood flow within 3 minutes, the situation may lead to oxygen under supply. it may be necessary to hand crank the pump or operate the cp5 manually in case of a pump control failure.
  • Action
    Cellplex is advising users that the affected pumps should not be used as an arterial pump. Prior to the use of the affected pumps, users are advised to rotate the speed encoders to ensure that complete smooth transition occurs. If there is excessive traction, DO NOT use the pump. Cellplex is advising that all affected pumps used as arterial pumps will be replaced by loan pumps until the correction is performed. All affected units will be corrected by Cellplex.

Device

Sorin Perfusion System - S5/C5 Heart Lung Machine
  • Modèle / numéro de série
    Sorin Perfusion System - S5/C5 Heart Lung MachineS5 Roller PumpProduct Code: 10-80-00Multiple Serial NumbersS5 Double Roller PumpProduct Code: 10-85-00Multiple Serial NumbersS5 Control Panel for Mast Roller Pump 150Product Code: 28-95-80Serial#: 50E60933, 50E60951 and 50E60946Pump Control Panel (CP5)Product Code: 60-02-60Serial #: 60E10351 and 60E10353ARTG Numbers: 108387, 94208
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Cellplex Pty Ltd

Manufacturer

Cellplex Pty Ltd