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Recall of Hemodialysis Acid Concentrates - Notice to Hospitals
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(PDF Version - 43 K)Contact: Health Products and Food Branch Inspectorate (HPFBI)
The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from Baxter Corporation.
Contact the company for a copy of any references, attachments or enclosures.
NOTICE TO HOSPITALS
Health Canada Endorsed Important Safety Information on Hemodialysis Acid Concentrates
July 3, 2008
To: Hospital Chief of Medical Staff
Please distribute to relevant Departments of Internal Medicine, Nephrology, Dialysis Units, Emergency Medicine, Pharmacy, Paediatrics, Anaesthesia, Geriatrics, Nursing, Intensive Care and/or other Departments as required and other involved professional staff, including all satellite units, and post this Notice in your institution. In addition, please ensure that all home hemodialysis patients affiliated with the hospital are notified of the recall and risk information.
Subject: Potential risk of cardiac arrhythmia due to mislabelling of certain lots of Hemodialysis Acid Concentrates
Baxter Corporation has recently become aware that product D12302M lot W8D23D0 may be mislabelled with information from product D12294M lot W8D23D1, either on the shipping carton or the actual product jug. The resultant risk of the mislabelling is potentially serious cardiac arrhythmia. Due to this potential product mislabelling, both product lots are being recalled. Baxter Corporation (Canada) is issuing a recall for the following product codes and lot numbers:
| Product Description | Product Code | Lot Number | Expiry Date |
|---|---|---|---|
| Concentrate Acid Na100, K1, Ca1 4.5 L | D12302M | W8D23D0 | April 2011 |
| Concentrate Acid Na100, K2, Ca.25 4.5 L | D12294M | W8D23D1 | April 2011 |
- Baxter Corporation has recently become aware that product D12302M lot W8D23D0 may be mislabelled with information from product D12294M lot W8D23D1, either on the shipping carton or the actual product jug. Both product lots are being recalled.
- The resultant risk of the mislabelling is potentially serious cardiac arrhythmia.
- Please immediately discontinue use and segregate the above listed product lots.
Because of this issue patients may be exposed to dialysis-concentrate concentrations of potassium one half of that expected (46 meq/L versus 90 meq/L). These concentrates generate dialysis bath solutions of potassium of 1 meq/L and 2 meq/L respectively. Greater differences between serum and dialysate potassium (increased difference with the potentially lower dialysate potassium concentration) are more likely to cause EKG changes and cardiac arrhythmia. This issue has the potential to increase the likelihood of a patient having an arrhythmia during dialysis. Risk is greatest for end stage renal disease patients as they have a significantly higher rate of cardiac deaths. About 20% of these deaths are due to arrhythmias. All patients undergoing clinical hemodialysis should continue to be monitored for signs of cardiac arrhythmia. Home patients should contact their dialysis centre for advice about their supplies of dialysate concentrate or if they have any concerns about their health related to this product.
As per the attached recall notification letter that followed our initial telephone notification, the product recall will be initiated by completing the attached Customer Reply Form and faxing it to Baxter Corporation at 905-281-6625. Returning the form promptly will notify Baxter that you have unused, affected inventory and a Customer Service Representative will contact you to make the arrangements for its return and credit.
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any cases of cardiac arrhythmia or other serious or unexpected adverse reactions in patients receiving Hemodialysis Acid Concentrates should be reported to Baxter Corporation (Canada) or Health Canada at the following addresses:
Baxter Corporation
4 Robert Speck Parkway, Suite 700
Mississauga, ON L4Z 3Y4
Phone: 1-800-387-8399; 1-866-968-7477 outside of regular business hours
Fax: 905-281-6420
Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
Ottawa, Ontario, K1A 0K9
Tel: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866-234-2345
Fax: 866-678-6789
CanadaVigilance@hc-sc.gc.ca
The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.
For other inquiries related to this communication, please contact Health Canada at:
Health Products and Food Branch Inspectorate (HPFBI)
E-mail: DGO-ADGO_BDG-BDGA@hc-sc.gc.ca
Tel: 1-800-267-9675
Fax: 450-928-4101
Sincerely,
original signed by
Pam Bobbette
Vice President, Quality
Baxter Corporation (Canada)
