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Baxter HomeChoice Automated Peritoneal Dialysis Systems recallZ-0946-2008 · Baxter Healthcare Renal Div · initiated Nov 20, 2007

Terminated All recalls posted in March 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Renal Div or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Unrecorded Infusion; If the system is powered down or a power failure occurs during a fill cycle, the HomeChoice system may not record the last 1-4 pump strokes infused into the patient when the power is restored. This situation may create a potential unrecorded delivery of approximately 15-60 mL of fluid being infused into the patient.

FDA root cause category: Device Design

What the company is doing

Urgent Product Recall letters dated 11/20/07 were sent via first class mail to all of the affected customers, informing them of the potential for overfill if the system is powered down or a power failure occurs during a fill cycle. A Baxter representative will contact the customer to schedule the software update which corects this anomaly. The accounts were requested to complete and return the enclosed Customer Reply Form, indicating that they have disseminated the information to their staff and home patients. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 1. Baxter sent a follow-up letter dated 3/17/08 to the consignees, accompanied by a copy of the 11/20/07 letter. The letter reiterated the information in the 11/20/07 letter, emphasizing the serious consequences of an overfill for neonates and young pediatric patients, and providing information describing the symptoms of excess fluid in the abdomen and steps to be taken if the user suspects overfill of a neonate or young pediatric patient. Baxter requested that Baxter be contacted if an overfill should occur so Baxter can perform a complete investigation into the event. The accounts were requested to complete and return the enclosed Customer Reply Form, indicating that they have disseminated the information to their staff and home patients. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 1.

Recall details

Recall number
Z-0946-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 20, 2007
Posted by the FDA
Mar 7, 2008
Recalling firm
Baxter Healthcare Renal Div
Quantity
71,261 units
Product code
FKX
FDA submissions
K923065
Distribution
Worldwide; USA, Australia, New Zealand, China, Hong Kong, the Philippines, Thailand, Asia, Canada, Algeria, Austria, Bahrain, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Iraq, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Lebanon, Lithuania, Malta, Morocco, The Netherlands, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Ukraine, Latin America and Japan.

Product description

Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, and T5C4441R, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A

Code information (models, lots, serial numbers)

All serial numbers released prior to 09/21/07

Other devices under the same FDA submission

3 devices cleared under K923065 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 45861).

Sources and updates

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