Events

Rappel de Sapphire Infusion Pump

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

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-2015-RN-00624-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-07-16
  • 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-2015-RN-00624-1
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notes supplémentaires dans les données
  • Cause
    Q core (the sapphire infusion pump original manufacturer) has received complaints from customers that when using the epidural mode with patient bolus, the amount of medication delivered may be greater than programmed. in the sapphire pump, as in all infusion systems, external factors may cause fluctuations in flow rate accuracy. investigation of these complaints determined that the deviation observed is exclusively related to the use of catheters with a gauge smaller than that used for the sapphire pump flow accuracy calibration. no patient injuries or deaths have been reported as a result of this issue.
  • Action
    To address this issue, Q Core Medical is providing an addendum to the User Manual to assist customers in (i) identifying whether the catheter utilized may cause over-delivery, (ii) better understanding the effect of back pressure and catheter size on the accuracy of the delivered volume, (iii) translating the catheter’s back pressure to the degree of flow deviation that can be expected, and (iv) contacting Hospira Representative to determine if and to what extent specific catheter/pump combinations are susceptible to over-delivery. Future versions of the User Manual will incorporate the information contained in the addendum. This action has been closed-out on 30/08/2016.

Device

Sapphire Infusion Pump
  • Modèle / numéro de série
    Sapphire Infusion PumpHospira List Number: 163113601/163123601Q Core Number (on pump): 15031-000-0001 /15032-000-0001ARTG Number: 201499
  • Manufacturer
    Hospira Pty Limited

Manufacturer

Hospira Pty Limited
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    DHTGA