Events

Retiro De Equipo (Recall) de Device Recall Hospira Plum A Infuser

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
    68672
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1050-2015
  • Fecha de inicio del evento
    2014-06-11
  • Fecha de publicación del evento
    2015-02-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128430
  • 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
    Plum a+ infusion system pole clamp assemblies were discovered to be cracked. if the knob on the pole clamp assembly is cracked, the infuser cannot be attached to the iv pole since the knob is used to tighten and loosen the grip of the pole clamp to the pole.
  • Acción
    Hospira contacted the the sole customer on June 11, 2014, to inform them of the issue of the potential impact to their Plum A+ infusers list 20792-04-25. Hospira requested that the customer to allow Hospira Field Service Representatives to inspect and replace the impact pole clamp assemblies. On June 12, 2013 Geneva Hospital approved Hospira's request to the inspection and replacement of the impacted pole clamp assemblies. On June 16, 2013 Hospira's Field Service personnel performed the on-site, visual inspection of the pole clamp assemblies and confirmed 15 units were cracked. Hospira determined to replace all 102 pole clamp assemblies that were received by Geneva Hospital. For further questions please call (800) 441- 4100.

Device

Device Recall Hospira Plum A Infuser
  • Modelo / Serial
    List Number: 20792-04-25;   Serial Numbers: 17737372 ; 17737375 ; 17737377 ; 17737378 ; 17737383 ; 17737385 ; 17737390 ; 17737394 ; 17737395 ; 17737396 ; 17737397 ; 17737398 ; 17737399 ; 17737400 ; 17737402 ; 17737405 ; 17737408 ; 17737409 ; 17737414 ; 17737416 ; 17737419 ; 17737420 ; 17737421 ; 17737422 ; 17737424 ; 17737425 ; 17737426 ; 17737429 ; 17737430 ; 17737431 ; 17737432 ; 17737433 ; 17737435 ; 17737438 ; 17737440 ; 17737442 ; 17737443 ; 17737444 ; 17737445 ; 17737446 ; 17737447 ; 17737448 ; 17737449 ; 17737450 ; 17737451 ; 17737452 ; 17737454 ; 17737456 ; 17737458 ; 17737459 ; 17737460 ; 17737462 ; 17737463 ; 17737464 ; 17737467 ; 17737470 ; 17737475 ; 17737476 ; 17737478 ; 17737479 ; 17737480 ; 17737483 ; 17737485 ; 17737486 ; 17737489 ; 17737490 ; 17737492 ; 17737498 ; 17737500 ; 17737501 ; 17737502 ; 17737506 ; 17737507 ; 17737508 ; 17737511 ; 17737514 ; 17737516 ; 17737518 ; 17737520 ; 17737521 ; 17737522 ; 17737524 ; 17737525 ; 17737526 ; 17737531 ; 17737533 ; 17737535 ; 17737539 ; 17737542 ; 17737545 ; 17737546 ; 17737550 ; 17737551 ; 17737556 ; 17737557 ; 17737558 ; 17737559 ; 17737560 ; 17737562 ; 17737564 ; 17737569 ; 17737575
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to New York.
  • Descripción del producto
    Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Assembly Part Number 820-95443-008. A cassette based multi-function infusion system. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual. The pole clamp assembly is used to provide a mechanism to tighten and loosen the grip of the pole clamp to remove the infuser from the IV pole.
  • 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