Events

Rappel de Device Recall Hospira, Inc.

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Hospira Inc..

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
    73799
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1832-2016
  • Date de mise en oeuvre de l'événement
    2016-03-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-03-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144995
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
    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
    Pump, infusion - Product Code FRN
  • Cause
    Firm's investigation determined that the proximal occlusion alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification metal cassette, resulting in an offset in proximal pressure.
  • Action
    Hospira Inc, sent an "URGENT MEDICAL DEVICE CORRECTION" letter on March 31, 2016, to the direct consignees of record via traceable mailing which included a data capture log containing a list of devices located with each customer. Delivery will be confirmed via traceable mailing. Consignees who further distributed the product were asked to notify their customers. Please take the following actions related to Urgent Medical Device Correction letter notification: 1. Inform potential users in your organization of this notification. 2. Complete the attached reply form and return it to the fax number or e-mail address on the form, even if you do not have the affected product. 3. If you have distributed the product further, notify your accounts that received the product identified above of this notification and ask them to contact Stericycle at 1-877-479-8088 (M-F, 8am-5pm ET) to receive a reply form. Hospira will contact you to make arrangements for your impacted Plum 360 I Plum A+ devices to be re-calibrated to correct this issue. :

Device

Device Recall Hospira, Inc.
  • Modèle / numéro de série
    PLum 360 devices with the following list number: 300100405, 300100406, 300100605 , 300101305 , 300102705 , 300105405 and 300106507.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    U.S. distribution : Natrionwide. Foreign :Brazil, Canada, Chile, Colombia, Ecuador, Guatemala, Mexico, Oman, Peru, Taiwan, Turkey, United Kingdom and Uruguay.
  • Description du dispositif
    The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser can deliver fluids over a broad range of infusion rates and is capable of Concurrent delivery from one or more rigid or flexible fluid containers. The Plum 360 || infuser features Concurrent, Secondary, and Piggyback infusions. A positive valving cassette allows two lines to be delivered at independent rates. The volume to be infused (VTBI) is delivered through one line to a patient. The two lines can be delivered in Concurrent mode (together) or Piggyback mode (one after another) without raising or lowering I.V. bags. The Plum 360 infuser also enables fluid pathway troubleshooting such as removing proximal air in line, without is disconnecting the patient line. || The Plum 360 can act as a stand-alone infuser, or in conjunction with the Hospira MedNet software to provide medication safety software at the point of care, with customized drug libraries to support hospital defined protocols by || clinical care area. In such a configuration, the Plum 360 infuser can communicate with systems on the network via Ethernet or state of the art wireless communication using an 802.11 a/b/g/n/, 2.4 GHz/5 GHz dual-band radio. The Plum 360 infuser and Hospira MedNet software interface with other hospital systems such as Electronic Health records, Electronic Medication Administration Records, Bar Code Point of Care, Real Time Location Services, and there systems. || Each infuser includes a Connectivity Engine (CE) which provides both wired Ethernet and wireless 802.11 a/b/g/ networking capabilities. The Plum 360 infuser interfaces with Hospira MedNet application software to download drug library and infuser software updates and enable auto-programming of the infuser.The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Adresse du fabricant
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    USFDA