Events

Safety Alert Or Field Safety Notices for MiniCap peritoneal dialysis disconnect cap with povidone-iodine

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Baxter Healthcare Ltd..

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
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2006/022
  • Date
    2006-03-22
  • Event Date Posted
    2014-12-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-minicap-peritoneal-dialysis-disconnect-cap-with-povidone-iodine-monitor-thyroid-function-in-patients-with-small-fill-volumes
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
    The povidone-iodine contained in the disconnect caps of these peritoneal dialysis sets has the potential to be a contributing factor to thyroid changes such as hypothyroidism. Patients more likely to be affected are infants and children with smaller peritoneal fill volumes, where higher dialysate concentrations of iodine can result.
  • Reason
    (baxter healthcare ltd.) potential to be a contributing factor to changes in thyroid such as hypothyroidism. (mda/2006/022).
  • Action
    The thyroid function should be monitored in patients with small peritoneal dialysate fill volumes, typically infants and children. In order to minimise iodine exposure, the contents of the peritoneal cavity should be drained to the drain receptacle prior to the initiation of the next fill cycle whenever clinically possible.Users should be aware of the advice in Baxter’s Safety Alert (see appendix in pdf).

Device

MiniCap peritoneal dialysis disconnect cap with povidone-iodine
  • Model / Serial
  • Product Description
    Baxter MiniCap peritoneal dialysis disconnect cap with povidone-iodine.
  • Manufacturer
    Baxter Healthcare Ltd.

Manufacturer

Baxter Healthcare Ltd.
  • Manufacturer Address
    Enquiries to the manufacturer should be addressed to:Surecall-Baxter Medical Information, Baxter Healthcare Ltd, Wallingford Road, Compton, Newbury, Berkshire RG20 7QWTel: 01635 206 345Fax: 01635 206 071E-mail: surecall@baxter.com
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    MHRA