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 B Braun Medical 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 112 09 18 000
  • Event Initiated Date
    2018-09-26
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13222
  • 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
    In the course of post market surveillance activities we discovered that the above specified power cords might get damaged at the device connector. in very rare cases, the device connector might break if heavy lateral force is applied (see figure 1). if exposed electrical contacts are touched the user might be opposed to the potential risk of an electrical shock.

Device

220-240V Unit Cable (power cord) for Infusomat fmS, Infusomat P and SpaceCover
  • Model / Serial
    Affected power cords have been manufactured by B Braun supplier HAWA in the period from July 2016 (marked as M7 Y6) until June 2018 (marked as M6 Y8). The affected power cord has been shipped together with one of the following products: Infusomat P Deutsch 230 V (8712174), Infusomat P Netherlands 230 V (8712190), Infusomat P Czech 230 V (8712344), Infusomat P English 230 V (8712379), SpaceCover Comfort (8713145), SpaceCover Standard (8713147), Infusomat fmS Deutsch 230 V (8715424), Infusomat fmS Danish 230 V (8715432), Infusomat fmS Spanish 230 V (8715459), Infusomat fmS French 230 V (8715521), Infusomat fmS English 230 V (8715548), Infusomat fmS Italian 230 V (8715564), Infusomat fmS Czech 230 V (8715580) and as separate 220-240V Unit Cable (34502718).
  • Product Description
    Infusion pumps, power cord
  • Manufacturer
    B Braun Medical Inc.

Manufacturer

B Braun Medical Inc.