System, Peritoneal, Automatic Delivery

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-10-29Open, ClassifiedSoftware design

  Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)

  Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.

• 2023-12-26Open, ClassifiedUnder Investigation by firm

  Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111

  Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic.

• 2023-12-14Open, ClassifiedProcess control

  Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479

  There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.

• 2023-04-01Open, ClassifiedProcess design

  Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.

  The electrical safety testing was not properly performed on the impacted devices and additional testing is required

• 2017-01-19TerminatedDevice Design

  APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical and home use settings.

  Customer complaints received for the presence of leaks

• 2016-01-27TerminatedDevice Design

  Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111

  The door latch may not fully close and the door may open unexpectedly. The door may make physical contact with anything near the door of the machine, including the patient. May cause injury, delay in treatment, or Increased Intraperitoneal Volume (IIPV) (overfill).

• 2015-11-17TerminatedDevice Design

  Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.

  Loud operating sounds, which was unacceptable to the end users when the device was powered on. The HomeChoice devices continue to perform as intended, as the issue is only associated with the noise coming from the device and not the function of it. May delay treatment if changing to a different system.

• 2015-03-18TerminatedProcess design

  The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.

  The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that connects the occluder blade to the manifold causing an unrecoverable system error, and/or 2) blade may separate from the back plate and cause Slow / No Flow alarm requiring therapy termination.

• 2015-02-02TerminatedDevice Design

  Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage: The recall device is indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD Systems in clinical and home use settings.

  Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage.

• 2015-01-29TerminatedNonconforming Material/Component

  HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.

  The keypad buttons on HomeChoice devices may be activated without the operator pressing them.