MiniCap peritoneal dialysis disconnect cap with povidone-iodine - monitor thyroid function in patients with small fill volumes

(Baxter Healthcare Ltd.) potential to be a contributing factor to changes in thyroid such as hypothyroidism. (MDA/2006/022)

From:
Medicines and Healthcare products Regulatory Agency
Published
17 December 2014
Message type:
Device safety information
Medical specialty:
Renal medicine
Issued:
22 March 2006

Deadline (action underway): 29 March 2006 - Deadline (action complete): 03 May 2006

Device

Baxter MiniCap peritoneal dialysis disconnect cap with povidone-iodine.

Problem

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.

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).

Action by

All nursing, medical and technical staff using these devices.

Distribution

  • NHS trusts in England - Chief Executives*
  • Healthcare Commission (CHAI) - Headquarters
  • Primary care trusts in England - Chief Executives

Please bring this notice to the attention of all who need to know or be aware of it. This will include distribution by:

Trusts to:SABS liaison officers for onward distribution to all relevant staff including:

  • Adult & paediatric intensive care units
  • Clinical governance leads
  • Consultant biochemists
  • Directors of pathology
  • Health & safety officers
  • Intensive care units
  • Medical directors
  • Neonatal intensive care units
  • Nursing executive directors
  • Paediatricians
  • Peritoneal dialysis units
  • Renal nurses
  • Renal physicians
  • Renal units and satellites
  • Risk managers
  • Special care baby units
  • Supplies departments

Healthcare Commission (CHAI) to:Headquarters for onward distribution to all relevant staff including:

  • Hospitals in the independent sector

Primary care trusts to:SABS liaison officers for onward distribution to all relevant staff including:

  • Clinical governance leads
  • Prison healthcare managers

Contacts

Details of manufacturer contacts and MHRA contacts for technical and clinical aspects.Change of address or removal from address list for Healthcare Commission.

Manufacturer

Enquiries to the manufacturer should be addressed to:

Surecall-Baxter Medical Information, Baxter Healthcare Ltd, Wallingford Road, Compton, Newbury, Berkshire RG20 7QW

Tel: 01635 206 345

Fax: 01635 206 071

E-mail: surecall@baxter.com

MHRA

Enquiries to the MHRA should quote reference number 2005/003/010/401/002 and be addressed to:

Technical aspects

Mr J Lefever or Dr C McNieMedicines & Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ

Tel: 020 7084 3262/3219 Fax: 020 7084 3209

E-mail:jim.lefever@mhra.gov.ukcatriona.mcnie@mhra.gov.uk

Clinical aspects

Mr J Plumb, Medicines & Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ

Tel: 020 7084 3128 Fax: 020 7084 3111

E-mail:jonathan.plumb@mhra.gov.uk

Change of address or removal from address list for Healthcare Commission

Healthcare Commission, Finsbury Tower, 103-105 Bunhill Row, London EC1Y 8TG

Tel: 020 7448 0842

E-mail: contacts@healthcarecommission.org.uk

Appendix

MDA/2006/022 - Full version

Published 17 December 2014
Contents

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