Events

Rappel de Device Recall Hospira Plum A Infuser

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
    68672
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1050-2015
  • Date de mise en oeuvre de l'événement
    2014-06-11
  • Date de publication de l'événement
    2015-02-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-11-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128430
  • 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
    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.
  • Action
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to New York.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    USFDA