Liberty® 050-87212Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,169 adverse event reports that list this exact device (DI 00840861100736), received between Nov 20, 2015 and Sep 26, 2026 — classified as 12 deaths, 768 injuries, 1,389 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1,396 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 2,169 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abdominal Pain; Chills; Fever; Nausea; Peritoneal effluent abnormal; Peritonitis; Vomiting

  MAUDE report 50908446 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this male peritoneal dialysis (PD) patient was diagnosed with peritonitis. The patient transitioned to in-center hemodialysis. Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (PDRN). The patient was initially diagnosed with peritonitis on (b)(6) 2026. The patient was experiencing abdominal pain and cloudy PD fluid. The patient went to the emergency room (ER) to have cultures drawn. The patient was diagnosed with peritonitis and subsequently admitted to the hospital. The patient was initially started on antibiotic therapy with intraperitoneal (IP) Vancomycin and Ceftazidime (dose, frequency, and duration unknown). The culture results were not received from the hospital, but the physician documented them as positive for Acinetobacter (no species). The patient¿s antibiotics were changed to Gentamicin (dose, frequency, and duration unknown). The patient was discharged on (b)(6) 2026 and they completed the antibiotic regimen. The patient was then seen at the PD clinic on (b)(6) 2026 due to cloudy PD fluid. The patient had PD cultures obtained. The patient was started on antibiotic therapy with intraperito

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50883809 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50874023 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  The Peritoneal Dialysis (PD) patient contact reported to Fresenius Medical Care (FME) Customer Service that the PD patient has peritonitis. Attempts to obtain additional information were unsuccessful.

  Patient problems: Peritonitis

  MAUDE report 50873418 ↗
• 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 they have two connectors and during their first fill the second connector started to leak so they finished their first fill and bypassed to dwell. The patient was going to disconnect that tubing set and connect a new one and TS advised to re-setup with all new supplies. The patient was connected at time of call. Additional information was requested, however to date has not been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863462 ↗
• MalfunctionSep 21, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841973 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Peritonitis

  MAUDE report 50826551 ↗
• MalfunctionSep 17, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809835 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50542807 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  A peritoneal dialysis registered nurse (PDRN) reported on that this peritoneal dialysis (PD) patient went into the hospital a few weeks prior with cardiac issues (unspecified). When the PDRN followed up, the patient had been diagnosed with peritonitis. Attempts to obtain additional information were unsuccessful.

  Patient problems: Peritonitis; Unspecified Heart Problem

  MAUDE report 50524486 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this 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 through (b)(6) 2026 due to peritonitis. Subsequent attempts to obtain additional clinical information (e.g., hospital records, discharge summary, medication records) were unsuccessful.

  Patient problems: Peritonitis

  MAUDE report 50297744 ↗
• MalfunctionAug 12, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50230288 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  A nurse reported that this peritoneal dialysis (PD) patient was bleeding (unknown source) and hospitalized. The patient was diagnosed with peritonitis. Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (PDRN). The patient was admitted to the hospital on (b)(6) 2026 with complaints of nausea, vomiting, abdominal soreness and a non-functioning PD catheter (not a Fresenius product). A PD culture was drawn on (b)(6) 2026. Prior to the patient going to the hospital, they were administered Vancomycin 1 gm intravenous (IV) infusion once and Fortaz 1 gm IV infusion once. No additional information pertaining to antibiotic therapy was provided. The patient¿s cultures resulted positive for Serratia liquefaciens. The white blood cell (WBC) count was 660 with 71% polymorphonuclear (PMN) cells. The patient was diagnosed with peritonitis on (b)(6) 2026. The patient¿s diagnoses were peritonitis and non-functioning PD catheter. The patient was switched to back-up home hemodialysis (HHD) for 3 weeks. The patient will resume PD if the catheter is functioning. The cause of the peritonitis event is unknown but is suspected to be a breach in as

  Patient problems: Abdominal Pain; Nausea; Peritonitis; Vomiting

  MAUDE report 50203723 ↗
• MalfunctionAug 11, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201865 ↗
• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  This female peritoneal dialysis (PD) patient reported that she was admitted to the hospital on (b)(6) 2026 due to peritonitis. Follow-up was conducted with the patient¿s peritoneal dialysis registered nurse (PDRN). The patient went to the emergency room (ER) on (b)(6) 2026 due to abdominal pain (not the 24th as initially reported). The patient was admitted to the hospital and diagnosed with peritonitis. No information pertaining to culture results or antibiotic therapy was available as the patient remains hospitalized. The cause of the peritonitis event is unknown. No further information is available.

  Patient problems: Peritonitis

  MAUDE report 50196460 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by a Peritoneal Dialysis (PD) nurse that this patient on PD therapy has peritonitis. There were no reported allegations that the event was caused by Fresenius product. Rather, it was stated the patient will not be doing home therapy (HT) and a request was made to cancel the PD order. In additional follow-up, the reporting PD nurse confirmed that on (b)(6)2026 the patient was seen in the outpatient PD clinic with symptoms of abdominal pain. The nurse stated the patient had a PD culture obtained (the same day) which grew the bacteria actinomycetes and had an elevated white blood cell (WBC) count (result not provided). The patient was treated with oral Levaquin (dose not provided) and intra-peritoneal (IP) Vancomycin and Cefepime (dosing not provided) for peritonitis. However, subsequently on (b)(6)2026, the patient was hospitalized for removal of the PD catheter (not a Fresenius product). At this time, the patient was switched to intravenous (IV) antibiotic therapy (details unknown). Additionally, the patient was transitioned to hemodialysis for renal replacement needs. The patient remained in the hospital at the time follow-up was performed and is expected to continu

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 50177600 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  A nurse reported a peritoneal dialysis (PD) patient was diagnosed with peritonitis on (b)(6) 2026. Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (PDRN). The patient remains hospitalized and is supposed to have the PD catheter (not a Fresenius product) removed. No further information pertaining to the peritonitis event was available.

  Patient problems: Peritonitis

  MAUDE report 50101975 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  A 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) reported being hospitalized due to an infection of the peritoneal cavity. An email response from the patient¿s PD registered nurse (PDRN) revealed the patient presented to the emergency room (ER) on (b)(6) 2026 with complaints of abdominal pain, chills, and cloudy peritoneal effluent fluid. A peritoneal effluent fluid culture and cell count (WBC = 1998 u/L, Polymorphs = 76%) were collected, and the patient was formally admitted. The patient was diagnosed with peritonitis and was treated with intraperitoneal (IP) Cefazolin 2000 mg daily for 14 days. The patient¿s peritoneal effluent culture result returned positive for Staphylococcus epidermidis, and the patient¿s antibiotic was continued. The patient continued to undergo CCPD therapy while hospitalized without any known issues and was discharged home on (b)(6) 2026. The PDRN reported the patient is recovering, and attributed causality to an unspecified touch contamination event. Following discharge, the patient resumed utilizing the same Libert

  Patient problems: Abdominal Pain; Chills; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50086814 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  On 21/Jul/2026, FMCRTG became aware this 66-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 due to peritonitis. Follow-up with the patient¿s PD registered nurse (PDRN) revealed the patient presented to the emergency room (ER) on (b)(6) 2026 with complaints of dull abdominal pain (rating 6/10). A peritoneal effluent fluid culture and cell count (WBC = >100 u/L, Polymorphs = 50%) were collected, and the patient was formally admitted. The patient was diagnosed with peritonitis and was initially treated with empiric intravenous (IV) Vancomycin and Cefepime (dosages, frequencies, durations not provided), which were transitioned to intraperitoneal (IP) Vancomycin, Cefepime, and Nystatin (dosages, frequencies, durations not provided). However, the patient¿s peritoneal effluent culture result returned positive for Staphylococcus epidermidis on (b)(6) 2026, and the patient¿s Vancomycin, Cefepime, and Nystatin were discontinued and replaced with IP Cefazolin for 14 days (dose, frequency not provided). The patient continued

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 50085069 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6)2026, it was reported that this patient on Peritoneal Dialysis (PD) was hospitalized with peritonitis. There were no reported allegations that the event was caused by Fresenius products. In additional follow-up call, the PD nurse confirmed that on (b)(6)2026 this patient was hospitalized with peritonitis characterized by symptoms of abdominal pain. The patient had a PD culture obtained (in the hospital) which was positive for growth of the bacteria streptococcus mitis. The patient was initiated on antibiotic therapy utilizing intra-peritoneal (IP) Vancomycin and Rocephin (dosing not provided). On (b)(6)2026, the patient was discharged from the hospital and continues PD therapy with the same cycler. 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 breach in aseptic technique/not wearing a mask during the PD exchange.

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 50083739 ↗
• MalfunctionJul 29, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50069891 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  A nurse reported that this patient on Peritoneal Dialysis (PD) was hospitalized with peritonitis. There were no reported allegations that the event was caused by Fresenius products. In additional follow-up call, the patient¿s PD nurse confirmed that on (b)(6) 2026 this patient was hospitalized with symptoms of abdominal pain and cloudy PD effluent. It was reported that the patient had a PD culture obtained (in the hospital) which was positive for growth of the bacteria Acinetobacter (species not provided). The patient was treated with antibiotic therapy utilizing Cefepime 1 gram every 24 hours intravenously (IV). Additionally, the patient underwent removal of the PD catheter (not a Fresenius product) and was transitioned to hemodialysis for renal replacement needs. On (b)(6) 2026, the patient was discharged from the hospital and is recovering from the event. The patient currently remains on hemodialysis on an outpatient basis. 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; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50046290 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this patient on Peritoneal Dialysis (PD) therapy was hospitalized with peritonitis. There were no reported allegations that the event was caused by Fresenius product. In additional follow-up, the patient¿s PD nurse confirmed that on (b)(6) 2026 the patient was hospitalized with symptoms of abdominal pain. The nurse stated the patient had a PD culture obtained in the hospital. However, the nurse did not have PD culture results available. Per the nurse, the patient was diagnosed with peritonitis and was initiated on intra-peritoneal (IP) Vancomycin and Cefazolin (dosing not provided). On (b)(6) 2026, the patient was discharged from the hospital and continued with PD with the same cycler. The nurse could not provide the exact cause for peritonitis. However, it was confirmed the patient did not have fluid leaks or any issues/malfunctions with Fresenius products in relation to the event.

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 50038423 ↗
• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS 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 DIAGNOSED WITH AN INFECTION ON (B)(6) 2026 AND WAS STARTED ON ANTIBIOTICS. DURING FOLLOW-UP, THE PATIENT¿S PD REGISTERED NURSE (PDRN) REPORTED THE PATIENT PRESENTED TO THE OUTPATIENT HOME DIALYSIS CLINIC ON (B)(6) 2026 WITH COMPLAINTS OF ABDOMINAL PAIN. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (CLOUDY, WBC = 1874 U/L, POLYMORPHS = 83%) WERE COLLECTED, AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS INITIALLY TREATED WITH INTRAPERITONEAL (IP) VANCOMYCIN 1500 MG EVERY 4 DAYS (BASED ON VANCOMYCIN TROUGH LEVEL), AND CEFTAZIDIME 1500 MG DAILY FOR 14 DAYS. HOWEVER, THE PATIENT¿S PERITONEAL EFFLUENT CULTURE RESULT RETURNED POSITIVE FOR ENTEROCOCCUS FAECALIS ON (B)(6) 2026, AND THE PATIENT¿S CEFTAZIDIME WAS DISCONTINUED AND REPLACED WITH ORAL AMPICILLIN 500 MG FOR 21 DAYS AND THE VANCOMYCIN WAS INCREASED TO EVERY 3 DAYS. THE PATIENT HAS RECOVERED FROM THE SERIOUS ADVERSE EVENTS AND HAS CONTINUED TO UNDERGO CCPD THERAPY UTILIZING THE SAME LIBERTY SEL

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 25891509 ↗
• InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PERITONEAL DIALYSIS (PD) PATIENT REPORTED BEING HOSPITALIZED DUE TO PERITONITIS. THE PATIENT COULD NOT REMEMBER THE ADMISSION DATE BUT PROVIDED (B)(4) 2026 AS THE DISCHARGE DATE. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2026 DUE TO ABDOMINAL PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DIAGNOSED WITH PERITONITIS. PD CULTURES WERE OBTAINED. THE PATIENT WAS INITIATED ON ANTIBIOTIC THERAPY WITH INTRAPERITONEAL (IP) VANCOMYCIN EVERY 5 DAYS FROM (B)(6) 2026 (DOSE NOT PROVIDED). THE CULTURES WERE POSITIVE FOR COAGULASE-NEGATIVE STAPHYLOCOCCUS WARNERI. THE DISCHARGE DATE WAS NOT CONFIRMED. THE CAUSE OF THE PERITONITIS EVENT WAS TOUCH CONTAMINATION. THE PATIENT CONTINUED CCPD TREATMENTS DURING RECOVERY.

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 25860860 ↗

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-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
• 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