HomeChoice PRO APD System 5C8310RRecalls & reported problems
Baxter International Inc. · The HomeChoice PRO Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00085412026350), received between Jul 10, 2024 and Jul 10, 2024 — classified as 1 malfunction.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Arrhythmia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PERITONEAL DIALYSIS PATIENT PASSED AWAY WHILE CONNECTED TO AN UNSPECIFIED CYCLER. IT WAS REPORTED THAT THE CAUSE OF DEATH "MIGHT BE AN ARRHYTHMIA ASSOCIATED WITH THE DIALYSIS". IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED PRIOR TO OR DURING THE EVENT. THERE WAS NO MEDICAL INTERVENTION REPORTED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Arrhythmia
MAUDE report 19712907 ↗
Other SYSTEM, PERITONEAL, AUTOMATIC DELIVERY devices
- Liberty® Select Cycler 180343Fresenius Medical Care Holdings, Inc. · System, peritoneal, automatic delivery1 recall545 deaths15,896 reports
- Liberty® 050-87216Fresenius Medical Care Holdings, Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY16 deaths9,148 reports
- Liberty® 050-87212Fresenius Medical Care Holdings, Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY12 deaths2,169 reports
- Liberty® 180111Fresenius Usa, Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY126 deaths1,716 reports
- Amia Automated PD Set with Cassette 5C5479Baxter International Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY1 recall976 reports
- INTERGRATED APD SET L5C4531Baxter International Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY811 reports
- Liberty 050-87216AFresenius Medical Care Renal Therapies Group, LLC · System, Peritoneal, Automatic Delivery1 death678 reports
- NA R5C4479Baxter Healthcare SA · System, peritoneal, automatic delivery373 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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