Events

Alerte De Sécurité sur Plum A+ Single Channel Family of Infusers

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.

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
    2012-11-06
  • Date de publication de l'événement
    2012-11-06
  • 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_20121106a.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 plum a+ single channel family of infusers the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning plum a+ single channel family of infusers, manufactured by hospira, inc. the affected list numbers were 11005, 11971, 12391 and 20792. hospira issued a field safety notice to inform users that the volume control knob on some plum a+ single channel infusers (located on the back of the infuser) may not function as described in the system operation manual; the direction for” loud” and “quiet” may be reversed. the manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise. in the event the healthcare professional rotates the volume control knob in the direction described in the system operation manual, the audible tone may be the opposite of the desired audio level. while the device will continue to alarm with an audible one of at least 50 dba at the lowest level, inadvertently setting a low tone when a louder level is actually intended may result in an audible alarm that is more difficult to hear. if this happens, it is possible the clinician may not be alerted when an alarm condition occurs and an interruption in therapy may occur. to correct the issue, hospira will update the system operating manual to clarify the instructions for setting the volume. furthermore, hospira will be creating a volume directional label as an additional improvement. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con199544 if you are in possession of the product, please contact your supplier for necessary actions. posted on 6 november 2012.

Device

Plum A+ Single Channel Family of Infusers
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Hospira Plum A+ Single Channel Family of Infusers
  • Manufacturer
    Hospira

Manufacturer

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