Public advisory

Baxter Corporation’s MiniCap Extended Life Peritoneal Dialysis Transfer Sets: Certain cleaning products, including hand sanitizers and solvents, may damage sets

Last updated

Summary

Product
MiniCap Extended Life Peritoneal Dialysis Transfer Sets manufactured by Baxter Corporation (see list of affected products)
Issue
Medical devices
What to do

 

  • Avoid direct contact between the transfer sets and the following cleaning products:
    • hand sanitizers and cleaning products that contain hydrogen peroxide, bleach, alcohol or antiseptic agents; and
    • solvents used to remove adhesive residue, such as those containing acetone, toluene, xylene or cyclohexanone
  • If your set is damaged (e.g., cracked or leaking), contact your health care provider immediately for a replacement.
  • Use proper cleaning practices to clean the device as outlined in the Instructions for Use or as directed by a health care professional.

Affected products

Product Company Product Code
Minicap Extended Life PD Transfer Set With Roller Clamp (15cm) Baxter Corporation 5C4449
Minicap Extended Life PD Transfer Set With Twist Clamp (15cm) Baxter Corporation 5C4482
Minicap Extended Life PD Transfer Set With Twist Clamp (Extra Long) (22cm) Baxter Corporation R5C4484
Minicap Extended Life PD Transfer Set With Twist Clamp (Extra Short) (10cm) Baxter Corporation 5C4483

Issue

Health Canada is advising patients who use MiniCap Extended Life Peritoneal Dialysis Transfer Sets, manufactured by Baxter Corporation, that direct contact between the sets and certain cleaning products, including hand sanitizers and solvents, may damage the sets.

Damaged sets could leak or crack, which may cause microbial contamination leading to the development of peritonitis in some cases. Peritonitis is the inflammation of the lining of the abdomen, caused by infection, which can be serious if not promptly treated. Symptoms include nausea, vomiting, and abdominal pain or tenderness. If you experience symptoms of peritonitis, seek medical attention immediately.

Damaged sets may also lead to a delay in therapy as you seek medical assistance to change your transfer set.

A transfer set is tubing that connects the catheter in the body to the bag of dialysis solution in the treatment of renal (kidney) failure. Using a transfer set helps protect the catheter from damage that may be caused by frequent clamping during dialysis exchange procedures. These transfer sets are installed by trained health care providers for use in health care and home settings. Peritoneal dialysis patients receiving dialysis at home need to open and close the transfer set several times a day to connect to fresh dialysis solution and drain existing solution from their abdomen.

Baxter Corporation has informed Health Canada that, to date, it has received 13 reports internationally of peritonitis possibly related to this issue, including one Canadian case. The company has also informed Health Canada that it has notified all affected customers (health care facilities), and will update the product Instructions for Use to warn that use of the following products should be avoided on the transfer sets:

  • hand sanitizers and cleaning products that contain hydrogen peroxide, bleach, alcohol or antiseptic agents; and
  • solvents intended to remove adhesive residue, such as those containing
    acetone, toluene, xylene, or cyclohexanone

The Department is monitoring the effectiveness of this corrective action and will inform Canadians if any new health risks are identified.

What you should do

  • Avoid direct contact between the transfer sets and the following cleaning products:
    • hand sanitizers and cleaning products that contain hydrogen peroxide, bleach, alcohol or antiseptic agents; and
    • solvents intended to remove adhesive residue, such as those containing
      acetone, toluene, xylene or cyclohexanone.
  • If your transfer set is damaged (e.g., cracked or leaking), contact your health care provider immediately for a replacement. Consult your health care provider with any questions or concerns about your transfer set.
  • Seek immediate medical attention if you experience symptoms of peritonitis. Symptoms include nausea, vomiting, and abdominal pain or tenderness. 
  • Use proper cleaning practices to clean the device, as outlined in the Instructions for Use or as directed by a health care professional.
  • You may also contact Baxter Corporation at 1-866-968-7477 if you have questions about this issue or about your transfer set.
  • Report any health product-related complaints to Health Canada.

Additional information

Details
Original published date:
Alert / recall type
Public advisory
Category
Health products - Medical devices
Companies
Published by
Health Canada
Audience
General public
Identification number
RA-63932
Media and public enquiries

Media Enquiries

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media@hc-sc.gc.ca

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