Liberty® 050-87216Recalls & reported problems

Summary

The FDA's MAUDE database contains 9,148 adverse event reports that list this exact device (DI 00840861100750), received between Nov 13, 2015 and Sep 30, 2026 — classified as 16 deaths, 2,900 injuries, 6,231 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6,227 reports).

10 other recalls cover devices cleared under the same FDA submission (K043363, K173718); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 9,148 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50954691 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Nausea; Peritonitis; Unspecified Gastrointestinal Problem; Vomiting

  MAUDE report 50950008 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacteremia; Chills; Fever; Peritonitis

  MAUDE report 50949678 ↗
• DeathSep 29, 2026Adverse Event Without Identified Device or Use Problem

  During follow-up for drain complications, it was reported that this peritoneal dialysis (PD) patient passed away. Additional information was obtained through follow-up with the charge nurse at the PD clinic. The patient had been admitted to the hospital on (B)(6) 2026 with a diagnosis of sepsis. PD effluent and cell count were drawn on either (B)(6) 2026 or (B)(6) 2026 which resulted positive for peritonitis. The culture results were not available. There was also concern for calciphylaxis. A biopsy had been scheduled. No information pertaining to antibiotics was available. On (B)(6) 2026, the patient¿s sister was present in the hospital with the patient and stated the patient ¿stopped breathing¿. The patient was a do not resuscitate (DNR), so no resuscitative efforts were performed. The cause of death was cardiac arrest. The patient¿s death was not related to any FME device, drug, product or dialysis treatment. It is unknown if the patient continued dialysis during the hospitalization. The cause of the peritonitis event is unknown. The patient had a prior history of myocardial infarctions, chronic obstructive pulmonary disease (COPD), diabetes mellitus (DM), and possible calciphyla

  Patient problems: Cardiac Arrest; Peritonitis; Sepsis

  MAUDE report 50937423 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Peritonitis

  MAUDE report 50936969 ↗
• MalfunctionSep 29, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936641 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abdominal Pain; Peritonitis; Vomiting

  MAUDE report 50925239 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50904764 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50904116 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50903974 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50903519 ↗
• MalfunctionSep 24, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888572 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  A nurse reported a patient with renal failure (RF) on continuous cyclic peritoneal dialysis "[CC(PD)]" utilizing a Liberty Select Cycler and Liberty Cycler Set for renal replacement therapy (RRT) was hospitalized for peritonitis due to user error. Follow-up with the patient¿s primary PD registered nurse (PDRN) verified the patient presented to the emergency room on (b)(6) 2026 with complaints of abdominal pain and cloudy peritoneal effluent fluid. A peritoneal effluent fluid culture and cell count (WBC elevated, result not provided) were collected, and the patient was formally admitted. The patient was diagnosed with peritonitis and was treated with intraperitoneal (IP) Vancomycin every 5 days, and Ceftazidime daily for 21 days. The patient¿s peritoneal effluent culture result returned positive for Methicillin Resistant Staphylococcus aureus on (b)(6) 2026, and the patient¿s Ceftazidime was discontinued. The patient continued to undergo CCPD therapy while hospitalized and is recovering from the serious adverse events. On (b)(6) 2026, the patient was sent to a rehabilitation hospital for strength training and occupational therapy. The patient continues to utilize his personal Libert

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50885177 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by a Peritoneal Dialysis (PD) nurse that this patient on PD was hospitalized for a PD related issue. There were no reported allegations that the event was caused by Fresenius products. In additional follow-up call, another PD nurse familiar with the patient confirmed that on (b)(6) 2026 this patient was hospitalized with symptoms of abdominal pain. Per the nurse, the patient had a PD culture obtained (in the hospital) which had growth of candida parapsilosis. The nurse indicated that the patient was initiated on antibiotic therapy in the hospital utilizing intravenous (IV) Cefepime, Cefazolin (dosing not provided) and antifungal therapy with IV micafungin (dose not provided). Additionally, the nurse stated that the patient underwent removal of the PD catheter (not a Fresenius product) and was switched to hemodialysis for renal replacement needs. The patient remained in the hospital at the time follow-up was performed. The patient¿s nurse confirmed that the patient did not have any fluid leaks or issues with Fresenius products in relation to the peritonitis event. The nurse stated that the peritonitis event was attributed to patient breach in aseptic technique.

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 50882301 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50876521 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  A peritoneal dialysis (PD) patient reported to Fresenius Medical Care Customer Support that the patient is in hospital. The patient contact advised the patient has peritonitis. Upon follow-up with the patient¿s PD registered nurse, it was reported that this patient was hospitalized on (b)(6) 2026 following abdominal pain and cloudy peritoneal effluent fluid. Peritoneal effluent fluid cultures and a white blood cell (WBC) count obtained and tested in the hospital on (b)(6) 2026 presented with Staphylococcus epidermidis in the culture and an elevated WBC count (exact count not reported). The patient was diagnosed with peritonitis due to touch contamination during CCPD therapy on the Liberty Select Cycler at home. The patient was prescribed Vancomycin, Cefepime and Gentamycin (routes, dosages and frequencies not reported) to address the infection while hospitalized. The patient¿s PD catheter (not an FME product) was removed due to the severity of infection as she was transitioned to hemodialysis (HD) for renal replacement therapy on a hospital provided HD device (unknown brand and model) for the duration of the admission. The patient had an uneventful hospital course, and she was disc

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50870603 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  On 9/Sep/2026, Fresenius Medical Care (FME) became aware this 46-year-old male patient with end stage renal disease (ESRD) on continuous cyclic peritoneal dialysis "[CC(PD)]" utilizing a Liberty Select Cycler and Liberty Cycler Set for renal replacement therapy (RRT) was hospitalized on (b)(6) 2026 due to stomach pain (abdominal pain) and constipation. During follow-up, the patients¿ PD registered nurse (PDRN) confirmed the patient presented to the emergency room on (b)(6) 2026 with complaints of abdominal pain and constipation. A peritoneal effluent fluid culture and cell count (WBC elevated, result not available) were collected, and the patient was formally admitted. The patient was diagnosed with peritonitis and was treated with intraperitoneal (IP) Vancomycin and Ceftazidime (dosages, durations, frequencies not available). The patient¿s peritoneal effluent culture result returned positive for Enterococcus faecalis on (b)(6) 2026, and the patient¿s antibiotics were discontinued and replaced with IP Gentamycin and Ampicillin (dosages, durations, frequencies not available). The patient is recovering from the serious adverse events and continues to undergo CCPD therapy. The PDRN at

  Patient problems: Abdominal Pain; Constipation; Peritonitis

  MAUDE report 50869537 ↗
• MalfunctionSep 23, 2026Fluid/Blood Leak

  A peritoneal dialysis (PD) patient contact reported to Fresenius Medical Care (FME) Technical Service (TS) on (b)(6)2026 that M83 Pump A Vs. B Volume Error alarm occurred in Fill 1 of 5 and the patient was connected during the incident. The Cycler has not been re-setup with new supplies. A Fluid Leak was discovered during Fill 1 of 5. Upon follow-up conducted on (b)(6)2026 the patient confirmed the reported event. The patient confirmed they did not experience any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event. The patient confirmed treatment was not completed on the day of the reported event. Per patient there were no external leaks from the solution bag or any other connections prior to, during, or after the event. The patient confirmed that there was fluid inside the cycler door. Per the patient they don¿t know what caused the leak since they checked the cassette and the lines and there were no visible damage or holes. The patient stated that they have resumed treatment on the cycler since then with no further issues. The sample is not available to be returned to the manufacturer for physical evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867140 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  On 4/Sep/2026, a patient contact reported to Fresenius Medical Care (FME) technical services this 60-year-old female peritoneal dialysis (PD) patient on continuous cyclic PD (CCPD) therapy utilizing the Liberty Select Cycler was hospitalized with an infection. There was no specific allegation that this event was related to a deficiency or malfunction of any FME device(s) or product(s) in the initial reporting. Upon follow-up with the patient¿s PD registered nurse, it was reported that this patient was hospitalized on (b)(6)2026 following abdominal pain and scantly blood-streaked peritoneal effluent fluid. It was explained that the outpatient clinic is awaiting hospital discharge paperwork and, as a result, diagnostic laboratory findings were not reported. The patient was diagnosed with peritonitis due to a break in aseptic technique during CCPD therapy on the Liberty Select Cycler at home. The patient was prescribed intraperitoneal (IP) Ceftazidime and IP Gentamycin (dosages and frequencies not reported) to address the infection while hospitalized. The patient was able to undergo continuous ambulatory PD (CAPD) utilizing hospital provided manual exchanges as CAPD was the preference

  Patient problems: Abdominal Pain; Hemorrhage/Blood Loss/Bleeding; Peritonitis

  MAUDE report 50863665 ↗
• MalfunctionSep 23, 2026Fluid/Blood Leak

  A peritoneal dialysis (PD) patient (Pt) reported to Fresenius Medical Care (FME) Technical Service (TS) on (b)(6)2026 that last night they got an Air detected in cassette message and when they removed the cassette there was fluid leaking in the cassette module. The patient wanted to know if they could use the cycler tonight. The TS advised the patient to allow the cycler to dry with door closed and use it for next treatment (tx). Additional information was requested, however to date has not been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863457 ↗
• MalfunctionSep 22, 2026Fluid/Blood Leak

  A peritoneal dialysis (PD) patient (Pt) reported to Fresenius Medical Care (FME) Technical Service (TS) on (b)(6)2026 that M31 Air Detected in Cassette warning occurred Fill 1 of 4 and the patient was connected during incident. A fluid leak was discovered while the patient was cancelling treatment. The TS advised discontinuing use of this cycler and replaced Cycler due to M31. The TS advised contacting the peritoneal dialysis registered nurse (PDRN) to inform of replacement. Additional information was requested, however to date has not been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849886 ↗
• MalfunctionSep 22, 2026Fluid/Blood Leak

  A peritoneal dialysis (PD) patient contact reported to Fresenius Medical Care (FME) Technical Service (TS) on (b)(6)2026 that M31 Air Detected in Cassette warning occurred Fill 4 of 5 and the patient was connected during the incident. The unused lines were clamped, and air bubbles were found in the patient line (PL). A fluid leak was discovered upon removing the cassette and the patient was not connected during incident. Fluid was discovered in the pump module area; Fluid was discovered on the external of the cassette. The TS advised to discontinue use of this cycler and replaced Cycler due to M31. The TS advised to contact peritoneal dialysis registered nurse (PDRN) to inform of replacement. Additional information was requested, however to date has not been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849845 ↗
• MalfunctionSep 22, 2026Fluid/Blood Leak

  A peritoneal dialysis (PD) patient (Pt) reported to Fresenius Medical Care (FME) Technical Service (TS) on (b)(6) 2026 that fluid was discovered during TX Complete - Step 9 Remove Cassette and the patient was not connected during incident. Fluid was discovered in the pump module area; Fluid leaked from pump module. There were alarms/warnings prior to leak; notice draining slowly. The film on the back of the cassette is not loose. The patient stated they had a hard time inserting the cassette, it popped out once it was in. Cycler was on when trying to insert cassette. Notice: Draining Slowly msg occurred and the Pt was connected during incident. Patient is not Empty and air bubbles were discovered in patient line also in the drain line. Additional information was requested, however to date has not been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849769 ↗
• MalfunctionSep 22, 2026Fluid/Blood Leak

  A peritoneal dialysis (PD) patient (Pt) reported to Fresenius Medical Care (FME) Technical Service (TS) on (b)(6) 2026 that fluid was discovered during TX Complete - Step 9 Remove Cassette and the patient was not connected during incident. Fluid was discovered in the pump module area, and fluid was discovered on the external of the cassette. Fluid leaked from the inside of the cycler door and there were alarms/warnings prior to leak. Advised discontinuing use of this cycler and replaced the Cycler due to Fluid Leak. The TS advised the patient to contact peritoneal dialysis registered nurse (PDRN) to inform of replacement. Additional information was requested, however to date has not been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849737 ↗
• MalfunctionSep 22, 2026Fluid/Blood Leak

  A peritoneal dialysis registered nurse (PDRN) reported to (b)(4) on 08/31/2026 that fluid was discovered during TX Complete - Step 9 Remove Cassette; The patient was not connected during incident. Fluid was discovered in the pump module area; Fluid leaked from unknown. There were alarms/warnings prior to leak; Notice draining slowly occurred prior the fluid leak. The PDRN stated that patient just had catheter surgery and stated that patient wiped down the inside of the CYC with bleach. Additional information was requested, however to date has not been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849685 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043363, K173718. One submission often covers many models, so check the product and lot details in each record.

• Z-2085-2021 · Apr 28, 2021 · Terminated
  026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting
• Z-2151-2019 · May 29, 2019 · Terminated
  Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows: (1) LIBERTY Lin
• Z-0693-2016 · Dec 15, 2015 · Terminated
  Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
• Z-0148-2014 · Oct 14, 2013 · Terminated
  Fresenius Liberty Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.
• Z-1674-2013 · Jun 3, 2013 · Terminated
  Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain lin
• Z-0799-2013 · Oct 12, 2012 · Terminated
  Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.
• Z-1448-2012 · Mar 30, 2012 · Terminated
  Fresenius Liberty Cycler Software, User Manuals, and Handi-Guides for acute and chronic peritoneal dialysis. Software versions earlier than 2.8. The Fresenius Liberty Cycler is in
• Z-0105-2011 · Sep 3, 2010 · Terminated
  LIBERTY Automated Peritoneal Dialysis System lntegrated Cycler Set with single stay safe patient connector and extended drain line PIN: 050-87216. manufactured for Fresenius Medica
• Z-0104-2011 · Sep 3, 2010 · Terminated
  LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Single Patient Connector) PIN: 050-87215. manufactured for Fresenius Medical Care, Waltham M
• Z-0103-2011 · Sep 3, 2010 · Terminated
  LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Dual Patient Connector) PIN: 050-87212, manufactured for Fresenius Medical Care, Waltham MA