Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Hospira Inc.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 063 01 13 000
  • Event Initiated Date
    2013-01-19
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2898
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Potential for the plum a+ nuid shield diaphragm to be out of specification and cause n250 -door open while pumping" or n1 00 •unrecognisable cassette" alarms. these alarms invoke audible and visual warnings to the user, which may occur during setup, infusion or performance verification testing (pvt) and will cause the device set up to be interrupted or the infuston to stop.

Device

Infusion pump, Plum A+ Family of Infusers.
  • Model / Serial
    11005 - Plum A+ Hyperbaric Infusion System 11971 + 12391 - Plum A+ single channel infusion system 12348 + 12618 - Plum A+3 infusion pump system 20678 - Plum A+3 infusion pump with Hospira MedNetTlil software 20792 - Plum A+ infusion pump with Hospira MedNet™ software
  • Product Description
    Hyperbaric Infusion System
  • Manufacturer
    Hospira Inc

Manufacturer

Hospira Inc
  • Manufacturer Parent Company (2017)
    Pfizer
  • Manufacturers representative
    AL-KAMAL Import, Riyadh, (01) 2181122
  • Source
    SFDA