Events

Alerte De Sécurité sur Intravascular Administration Sets

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Hospira Inc.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-08-15
  • Date de publication de l'événement
    2013-08-15
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130815a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
    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
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: hospira intravascular administration sets the united states food and drug administration (fda) has issued a medical device safety alert concerning intravascular administration sets, manufactured by hospira inc. please see below the list number of the affected products: 14200-04-28: secondary blood set 14203-04-28: blood set 14206-04-28: y-type blood set 14207-04-28: blood set 14210-04-28: plum blood set 14211-04-28: plum blood set 14212-04-28: plum y-type blood set 14217-04-28: y-type blood set 14219-04-28: y-type blood set according to the fda, it was discovered that there was a potential for the piercing pin on certain iso-compliant hospira blood sets to puncture the outer wall of the non-iso-compliant blood bags during insertion of the pin into the blood bag. this can lead to the leakage of blood and health care provider exposure to blood products. a delay of therapy may also occur and in some cases result in serious adverse health consequences or death. at this time, there is no need for customers to discontinue use of or return hospira blood sets. the manufacturer recommends users exercise extreme caution when piercing blood bags with a hospira blood set mentioned above. the affected users are advised to make sure that all instructions for use included with the blood bag and protocol for spiking blood bags are completely followed, to minimize the possibility of puncturing the outer wall of the blood bag. the manufacturer has begun distribution of sets with a blunter, shorter piercing pin than the affected sets. these sets became available in march, 2013. for details, please visit the following fda websites: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm?action=detail&id=65689&w=08142013&lang=eng http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm364973.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm364988.Htm http://www.Fda.Gov/safety/recalls/ucm364935.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 august 2013.

Device

Intravascular Administration Sets
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Hospira Intravascular Administration Sets
  • Manufacturer
    Hospira Inc

Manufacturer

Hospira Inc
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    DH