HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems - Important Safety Information - Notice to Hospitals

Starting date:

April 3, 2013

Posting date:

April 8, 2013

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

Healthcare Professionals

Identification number:

RA-26519

This is duplicated text of a letter from Baxter Corporation. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

NOTICE TO HOSPITALS - Health Canada Endorsed Important Safety Information on HomeChoice and HomeChoice PRO Automated PD Systems

April 3, 2013

Dear Health Care Professional:

Please distribute to the Peritoneal Dialysis (PD) Program, Nephrology In-Patient Unit and other involved professional staff and post this NOTICE in your institution.

Subject: Unintended Increased Intraperitoneal Volume (IIPV) with HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis (APD) Systems

Baxter, in conjunction with Health Canada is providing this notice to reinforce the importance of proper programming to reduce the potential for unintended Increased Intraperitoneal Volume (IIPV) or overfill of the abdomen in patients using the HomeChoice and HomeChoice PRO APD Systems. Unintended IIPV can occur if the prescription parameters are not programmed appropriately in the dialysis systems and this can lead to serious injury or death.

Baxter is in process of upgrading all HomeChoice cyclers to software version 10.4 to reduce the potential for IIPV situations or events. A review of Post Market Surveillance data on HomeChoice cyclers with software version 10.4 has revealed that IIPV events might still occur predominantly in Tidal APD, associated with incorrect programming of therapy parameters.

• IIPV can result in serious injury or death from conditions including, but not limited to, hydrothorax, heart failure, pulmonary edema or pericardial effusion.
• Clinicians must carefully program patient fill volumes to prevent unintended IIPV situations. Clinicians must also program drain alarms and ultrafiltration percentage to ensure patients are draining sufficiently. The prescription settings may need to be reconsidered as well, if IIPB has occurred.
• Clinicians should remind patients and caregivers about the importance of following product instructions for use to prevent patient use errors.
• Should IIPV occur, follow the product instructions for use which provide guidance on how to address IIPV situations.

Additional Information

Correct programming, particularly of the total ultrafiltration (UF) and the minimum drain volume percentage (MDV%) in Tidal automated peritoneal dialysis (Tidal APD) should be reinforced. Two relevant causes of IIPV in Tidal APD include programming the MDV% too low and inappropriate programming of total UF. The following mitigations address these relevant causes of IIPV, however please refer to the Patient At-Home Guide for additional guidance on IIPV.

• Clinicians must carefully program parameters to ensure patients are draining sufficiently. Insufficient draining could lead to an IIPV situation during their subsequent cycle or accumulation of UF volume over multiple cycles.
• Proper programming of MDV% is an important parameter as it is used to determine whether the system alarms or moves on to the next fill whenever a Slow Flow or a No Flow condition occurs during drain. This is true in all APD, including Tidal. Setting MDV% too low can be associated with a higher risk of IIPV due to residual fluid building up over the course of the successive cycles.
• The Total UF setting in Tidal APD should be programmed as closely as possible to the patient’s actual UF. Programming Total UF to a lower value than actual amount of UF will cause a gradual buildup of ultrafiltrate during the therapy that can possibly lead to an IIPV situation.
• Programming Tidal Full Drains in Tidal APD can also reduce the potential for an IIPV event by performing one full (non-Tidal) drain every n cycle. This reduces the accumulation of ultrafiltrate throughout the duration of the Tidal APD especially if Total UF is underestimated.

Use errors that increase the risk of unintended IIPV are defined within the HomeChoice APD Systems Patient At-Home Guide and should be emphasized with the patient.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious unintended IIPV or other serious or unexpected adverse incidents for medical devices in patients using HomeChoice and HomeChoice PRO APD Systems should be reported to Baxter Corporation or Health Canada at the following addresses:

Baxter Corporation

7125 Mississauga Rd, Mississauga, Ontario L5N 0C2

1-800-553-6898, Prompt 1

To correct your mailing address or fax number, contact Baxter Corporation.

Any suspected adverse incident can also be reported to:

Health Products and Food Branch Inspectorate

HEALTH CANADA

Address Locator: 2003D

Ottawa, Ontario K1A 0K9

Telephone: The Inspectorate Hotline 1-800-267-9675

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada Web site.

For other medical device inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate

E-mail: mhpd_dpsc.public@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738

Sincerely,

original signed by

Phil Lynch

Director, Quality,

Baxter Corporation

Baxter, HOMECHOICE AND HOMECHOICE PRO are registered trademarks of Baxter International, Inc.