Liberty® Select Cycler 180343Recalls & reported problems

Summary

The FDA's MAUDE database contains 15,896 adverse event reports that list this exact device (DI 00840861102068), received between Nov 22, 2017 and Sep 30, 2026 — classified as 545 deaths, 3,264 injuries, 12,085 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5,969 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K171652, K181108, K222318); 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 16, 2026.

Recalls naming this device

1. Oct 24, 2023Open, Classified

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

   Z-0619-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 15,896 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 50954693 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50950005 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacteremia; Chills; Fever; Peritonitis

  MAUDE report 50949676 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Peritonitis

  MAUDE report 50938022 ↗
• 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 calciphylaxis.

  Patient problems: Cardiac Arrest; Peritonitis; Sepsis

  MAUDE report 50937420 ↗
• MalfunctionSep 29, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936634 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  This female peritoneal dialysis (PD) patient reported they have peritonitis. Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (PDRN). The patient was seen in the PD clinic on (b)(6) 2026 due to cloudy PD effluent and abdominal pain. The patient had PD cultures drawn. The patient was diagnosed with peritonitis. The patient was initiated on antibiotic therapy with intraperitoneal (IP) Ceftazidime 1g daily for 21 days. The culture resulted positive for Klebsiella pneumoniae. The patient did not require hospitalization. The cause of the peritonitis event is undetermined. The patient denies any break in sterile technique. No report of a cassette or solution leak was reported. The patient continues to complete PD therapy during recovery.

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50927094 ↗
• MalfunctionSep 29, 2026Sparking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926771 ↗
• InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50908447 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50904103 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abdominal Pain; Lethargy; Peritonitis

  MAUDE report 50900471 ↗
• MalfunctionSep 24, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888450 ↗
• 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 50883111 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50876520 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50874018 ↗
• 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 50873423 ↗
• MalfunctionSep 23, 2026Thermal Decomposition of Device

  A peritoneal dialysis registered nurse (PDRN) reported to Fresenius Medical Care (FME) Technical Support (TS) on (b)(6) 2026 that there was a burning smell coming from the cycler. The PDRN will not use this cycler and is requesting a replacement. At that point in time, the technical support representative advised the PDRN to discontinue using the cycler and a replacement cycler was issued due to the burning smell. Additional information was requested, however to date has not been provided. The cycler was returned to the manufacturer, and a replacement cycler was provided. Upon physical evaluation of the cycler by the manufacturer, evidence of an internal short on the transformer on the inverter board was identified.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870267 ↗
• 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 50869647 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  A peritoneal dialysis (PD) patient contact reported to Fresenius Medical Care Customer Support that the patient went into the hospital yesterday. The patient did a manual exchange over the weekend and her fluid was cloudy. The patient was advised that she has an infection but test results have not come back to determine if her infection is peritonitis. Follow-up with the patient¿s PD registered nurse (PDRN) confirmed 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 unavailable) 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 negative for growth; however, the patient¿s antibiotic regimen will continue. The patient continued to undergo CCPD while hospitalized and was discharged home in stable condition on (b)(6) 2026. The patient is recovering and continues to utilize the same Liberty Select Cycler following discharge without

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50869106 ↗
• MalfunctionSep 23, 2026Fluid/Blood Leak

  A peritoneal dialysis (PD) patient contact reported to Fresenius Medical Care (FME) Technical Service (TS) on 09/05/2026 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 09/10/2026 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 50863575 ↗
• 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 M31 Air Detected in Cassette warning occurred Fill 1 of 5 and the patient was connected during the incident. Fluid was seen in the pump module area and the film on the back of the cassette is loose. MWD - Watchdog Timer Error; Alarm occurred in Power Fail Recovery. Fluid was discovered during TX Complete - Step 9 Remove Cassette. Fluid was discovered in the pump module area and on the external of the cassette. Fluid leaked from unknown location; There were alarms/warnings prior to leak; M31 Air Detected In Cassette occurred prior the fluid leak. Additional information was requested, however to date has not been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863488 ↗
• 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 50863437 ↗
• MalfunctionSep 23, 2026Overfill

  A peritoneal dialysis (PD) patient (Pt) reported to Fresenius Medical Care (FME) Technical Service (TS) on(b)(6)2026 that Fill Complication Encountered message occurred in Fill 1 of 5 and the patient was connected during the incident. The patient experienced an increased intraperitoneal volume (IIPV) event coincident with their peritoneal dialysis (PD) therapy on (b)(6)2026. The event was discovered while reviewing the patient¿s treatment records. A review of the patient¿s treatment records identified that the patient drained (b)(6) during drain 4 of the treatment. This drain volume for drain 4 is (b)(6) of the patient's prescribed fill volume of (b)(6). As a result of the IIPV event, the technical support representative advised replacing the cycler due to the IIPV being over (b)(6), but patient declined stating that they do not believe it's the cycler. Pt believes the issue is the catheter, and they are working along the Dr to figure out what is causing the Pt to have notice draining slowly message throughout the night and at a daily basis. Pt will continue with the Tx. Upon follow-up conducted on (b)(6)2026, the patient confirmed the reported event. The patient confirmed they did

  Patient problems: Increased Intra-Peritoneal Volume (IIPV)

  MAUDE report 50863432 ↗
• MalfunctionSep 22, 2026Fluid/Blood Leak

  A peritoneal dialysis (PD) patient (Pt) reported to Fresenius Medical Care (FME) Technical Service (TS) on 09/01/2026 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 50849897 ↗
• 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 50849873 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171652, K181108, K222318. One submission often covers many models, so check the product and lot details in each record.

• Z-0439-2021 · Sep 12, 2020 · Completed
  Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
• Z-1365-2018 · Jan 24, 2018 · Terminated
  Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis.