Liberty® 026-20036ARecalls & reported problems
Fresenius Medical Care Holdings, Inc. · Liberty® Drain Line · Class 2
All models of Liberty (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840861101115), received between Nov 26, 2021 and Nov 26, 2021 — classified as 1 injury.
1 FDA recall record name this device's identifier.
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 16, 2026.
Recalls naming this device
- Apr 28, 2021Terminated
Exposed to freezing temperatures due to refrigerated truck malfunctions
Z-2085-2021 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Fall1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PERITONEAL DIALYSIS (PD) PATIENT REPORTED THAT THEY FELL DOWN AFTER TRIPPING OVER THE DRAIN LINE FROM THE PREVIOUS NIGHT¿S TREATMENT. THE PATIENT REQUIRED ASSISTANCE WITH GETTING UP AND PRESENTED TO THE EMERGENCY ROOM (ER) TO HAVE FLUID DRAINED FROM THEIR KNEES. THE PATIENT CONFIRMED THAT THEY WERE NOT CONNECTED TO THE CYCLER WHEN THE EVENT OCCURRED. THE PATIENT¿S PD REGISTERED NURSE STATED DURING FOLLOWUP THAT THE PATIENT¿S FALL WAS DUE TO A HISTORY OF LOWER EXTREMITY WEAKNESS THAT IS RELATED TO CARDIOVASCULAR DISEASE AND UNRELATED TO PD THERAPY. IT WAS STATED ANY FLUID THAT HAD TO BE REMOVED WAS DUE TO FLUID RETENTION FROM POORLY CONTROLLED CONGESTIVE HEART FAILURE. ADDITIONALLY, IT WAS REPORTED THE PATIENT HAS ADVANCING END-STAGE RENAL DISEASE WITH MEMBRANE FAILURE. THE PATIENT PLANS TO TRANSITION TO HEMODIALYSIS (HD) FOR RENAL REPLACEMENT THERAPY AS PD IS NO LONGER SUFFICIENT. IT WAS CONFIRMED THE PATIENT¿S FALL OVER THEIR DRAIN LINE, FLUID REMOVAL FROM THEIR KNEES AND THE ASSOCIATED ED VISIT WERE NOT DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S). THE PATIENT CONTINUES CCPD THERAPY ON A NEWLY RECEIVED LIBERTY SELECT CYCLER WITH PLANS TO TRANSIT
Patient problems: Fall
MAUDE report 12878193 ↗
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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