Events

Retiro De Equipo (Recall) de Device Recall Plum XL

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Hospira Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    67453
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1703-2014
  • Fecha de inicio del evento
    2014-01-24
  • Fecha de publicación del evento
    2014-06-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125502
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Pump, infusion - Product Code FRN
  • Causa
    There is the potential for the door roller assembly on the plum lifecare 5000 series and plum xl families of infusers to break. in the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. depending on the conditions of a broken door roller pin, a number of events can occur. the door cannot be closed or a cassette/door alarm or a false occlusion.
  • Acción
    Hospira sent an URGENT MEDICAL DEVICE RECALL letter dated January 24, 2014, to all affected customers via traceable UPS. The letters included instructions for recipients to: inspect the door roller assemblies; if a door roller or pin appears loose, broken or missing, remove the device from clinical service until the door assembly is replaced with a corrected door assembly and contact Hospira at 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST) to report the issue. All devices requiring repair will be serviced and replaced with the existing design door and/or pin. Hospira is in the process of designing a metal door roller pin to replace the plastic on currently available on the Plum XL and once that design is complete, any door roller/pin serviced on a Plum XL will be replaced with the new metal design. Recipients are further instructed to: inform potential users in their organization of the recall notification; complete the attached reply form and return it to the fax number or e-mail address on the form; and if the pumps were further distributed, to notify the accounts that received the devices and ask them to contact Stericycle at 877-597-9581 (Monday - Friday, 8:00 AM - 5:00 PM EST) to receive a reply form. The URGENT MEDICAL DEVICE RECALL letter also reports that Hospira is in the process of retiring the Plum LifeCare 5000 and Plum XL families of infusion devices as noted in the IMPORTANT PLUM INFUSION PUMP DISCONTINUATION AND TRANSITION NOTICE issued May 1, 2013. As of June 30, 2015, Hospira will consider the products within the Plum LifeCare 5000 and Plum XL Infusion Systems families retired and will no longer support them. For questions regarding this recall call 224-212-2000.

Device

Device Recall Plum XL
  • Modelo / Serial
    List Number: 11555; Serial Numbers: All.  List Number: 11855; Serial Numbers: All.  List Number: 11859; Serial Numbers: All.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA nationwide including District of Columbia, Puerto Rico, and US Virgin Islands; Australia, Argentina, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Jordan, Kuwait, Luxembourg, Mexico, Oman, Peru, Poland, Portugal, Qatar, Russia, San Marino, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Yemen.
  • Descripción del producto
    Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Dirección del fabricante
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    USFDA