Dianeal peritoneal dialysis solution and various irrigation solutions

Recall - risk of adverse events due to potential dilution

10 April 2015

Consumers and health professionals are advised that Baxter Healthcare, in consultation with the TGA, has initiated a recall of certain batches of Dianeal peritoneal dialysis solution and various irrigation solutions (see below for a list of affected products) due to the potential that these products may have been diluted with water for injection during manufacture.

Dianeal peritoneal dialysis solutions are used during peritoneal dialysis, a process that removes toxins and waste products from the bodies of people with kidney disease. The solution can be used in hospitals and by patients for self-treatment in their homes.

Irrigation solutions can be for various purposes, including during surgical procedures to cleanse tissue.

Following an investigation into the hospitalisation of a patient with serious hyponatraemia after using a 6 litre Dianeal peritoneal dialysis solution, it was found that some bags of solution from the same batch had been diluted and did not contain the correct levels of active ingredients. The batch, numbered S87W2, was recalled and Baxter Healthcare provided hospitals and patients further information and alternative products.

Further investigation by Baxter Healthcare has identified additional batches of Dianeal peritoneal dialysis solution and various irrigation solutions (listed below) that were manufactured in the same facility, using the same manufacturing process, which could potentially be affected by the dilution error.

As a precaution, Baxter Healthcare has extended the initial recall to all potentially affected products and is contacting hospitals and patients to provide further information and alternative products.

The TGA is continuing to work with Baxter Healthcare to address the root cause of the problem and ensure appropriate corrective actions are implemented. Manufacturing has been suspended until these corrective actions have been completed. Please note that the stock being recalled represents a small proportion of Baxter Healthcare's current inventory of peritoneal dialysis solution in Australia and no supply shortages are expected as a result of this issue.

As of 9 April 2015, there have been no other reports of patients experiencing problems as a result of this issue.

The affected products are:

Peritoneal dialysis solution
Product code Description Batch number Manufactured Expiry Last shipped in Australia
AHB5288L* Dianeal PD4 2.5% Glucose 6 Litre for APD # S87W2 Febuary 2015 28 Febuary 2017 2 April 2015
AHB5289L Dianeal PD4 4.25% Glucose 6 Litre for APD # S68X5 January 2014 31 January 2016 31 March 2015
AHB9807R Dianeal PD4 1.5% Glucose Freeline Solo 2 Litre for CAPD # # S73X1 May 2014 31 May 2016 20 Febuary 2015
AHB5282L Dianeal PD4, 1.5% Glucose 6 Litre for APD # S60S6 August 2013 31 August 2015 8 November 2013
AHB5288L Dianeal PD4 2.5% Glucose 6 Litre for APD # S62F2 August 2013 31 August 2015 21 November 2013
AHB5282L Dianeal PD4 1.5% Glucose 6 Litre for APD # S67P3 December 2013 31 December 2015 10 Febuary 2014
AHB5282L Dianeal PD4 1.5% Glucose 6 Litre for APD # S67W6 January 2014 31 January 2016 4 April 14

* Initial recalled batch
# Automated peritoneal dialysis
# # Continuous ambulatory peritoneal dialysis

Irrigation solution
Product code Description Batch number Expiry
AHB7316 1.5% Glycine Irrigation S63S1 30 September 2015
AHB7616 0.9% Sodium Chloride for Irrigation S66P2 30 November 2015
AHB7616 0.9% Sodium Chloride for Irrigation S71N8 31 March 2016
AHB7317 1.5% Glycine Irrigation Solution S74P6 31 May 2016
AHB7127 0.9% Sodium Chloride for Irrigation S82F6 31 October 2016

Information for consumers

Baxter Healthcare is contacting patients who use Dianeal peritoneal dialysis solution, providing further information about this issue.

As of 9 April 2015, there have been no further reports (beyond the hospitalisation that led to the initial recall) of patients experiencing problems associated with this issue in Australia.

Please note that the affected irrigation solutions, if diluted, pose a lower risk to patients than the peritoneal dialysis solutions.

All affected products are being removed from the market and manufacturing has been suspended until corrective actions to address this issue have been completed.

If you or someone you care for use Dianeal peritoneal dialysis solution for self-treatment in your home, check any solution that you have to ensure that it is not from an affected batch. If you have solution from an affected batch, do not use it. Baxter Healthcare will provide alternative products.

You should not stop peritoneal dialysis without first consulting with your health professional.

If you have any questions or concerns about this issue, talk to your health professional or contact Baxter Healthcare on 1300 789 646.

Information for health professionals and hospitals

Baxter Healthcare has contacted affected hospitals and patients, providing further information about this issue.

Check stock to see if you have any products from the affected batches. If you do, remove those products and contact Baxter Healthcare to arrange return of the products.

If you are treating a patient who uses Dianeal peritoneal dialysis solution for self-treatment in their home, ensure that they are aware of this issue.

If you have any questions or concerns about this issue, contact Baxter Healthcare on 1300 789 646.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.