Liberty 050-87216ARecalls & reported problems

Summary

The FDA's MAUDE database contains 678 adverse event reports that list this exact device (DI 00840861102716), received between Sep 4, 2024 and Sep 29, 2026 — classified as 1 death, 393 injuries, 284 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (287 reports).

1 other recall cover devices cleared under the same FDA submission (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 678 reports, in the reporter's own words as published by the FDA.

• 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; Nausea; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50927106 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  A nurse reported a peritoneal dialysis (PD) patient was hospitalized due to peritonitis. Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (PDRN). The patient had been seen in the PD clinic on (b)(6) 2026 due to drain issues. Patency was checked without issues and the patient had clear effluent at that time. The patient went to the hospital on (b)(6) 2026 due to abdominal pain and vomiting. The patient was admitted to the hospital. On (b)(6) 2026, PD cultures were drawn. The patient was diagnosed with peritonitis. The patient was initiated on antibiotic therapy with Cefepime in normal saline (NS) 500mg/50mL intravenous piggy-back (IVPB) every 12 hours and Vancomycin 1000mg in sodium chloride 0.9% NS 250mL IVPB (frequency and duration unknown). The patient¿s white blood cell (WBC) count was >50,000. The PD cultures were positive for gram positive cocci with moderate growth, Staphylococcus epidermidis. The patient remains hospitalized. The patient continues CCPD therapy in the hospital. The suspected cause of the peritonitis episode is lack of aseptic technique.

  Patient problems: Abdominal Pain; Peritonitis; Vomiting

  MAUDE report 50910598 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50891593 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  A peritoneal dialysis (PD) patient's wife reported that the patient was hospitalized for 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. The nurse indicated that the patient had a PD culture obtained (in the hospital) but the results were no available during follow-up. However, per the PD nurse, the patient¿s nephrologist, the bacteria isolated in the PD culture is associated with cat hair. The patient was initiated on intra-peritoneal (IP) antibiotic therapy utilizing Ampicillin (dose unknown). 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 indicated that this bacterium is associated with cat hair. The nurse stated that the peritonitis event was attributed to patient breach in infection control in the home environment where the patient has a pet cat.

  Patient problems: Peritonitis

  MAUDE report 50883810 ↗
• InjurySep 23, 2026Fluid/Blood Leak

  Patient problems: Peritonitis

  MAUDE report 50873111 ↗
• 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 50869308 ↗
• MalfunctionSep 23, 2026Fluid/Blood Leak

  A peritoneal dialysis (PD) patient (Pt) reported to Fresenius Medical Care (FME) Technical Service (TS) on 09/03/2026 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 50863496 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 50849124 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this female peritoneal dialysis (PD) patient was admitted to the hospital on (b)(6) 2026 with an infection. It was not determined if the infection was peritonitis. Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (PDRN). The patient contacted the PDRN on (b)(6) 2026 in tears due to shortness of breath and abdominal pain. The patient called 911 and was transported to the hospital. The patient was admitted to the hospital with a diagnosis of peritonitis. The nephrologist reported that the cultures were positive for Pseudomonas (no species provided). No information was available pertaining to antibiotic therapy. The cause of the peritonitis event is unknown. The patient remains hospitalized. No additional information was available.

  Patient problems: Abdominal Pain; Dyspnea; Peritonitis

  MAUDE report 50813024 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2026, it was reported that this patient on Peritoneal Dialysis (PD) therapy was hospitalized for 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 weakness. 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 initiated on antifungal therapy intravenously (IV); details are unknown. 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 in the setting of the patient having failure to thrive.

  Patient problems: Muscle Weakness/Atrophy; Peritonitis

  MAUDE report 50791645 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this patient on Peritoneal Dialysis (PD) therapy had peritonitis. There were no reported allegations that the event was caused by Fresenius products. In additional follow-up, the patient¿s PD nurse confirmed that on (b)(6) 2026 the patient was hospitalized for a left lower leg amputation; unrelated to dialysis. Per the nurse, it is believed that the patient¿s used his home cycler (Fresenius cycler) during hospitalization for PD therapy. Approximately 10 days into the patient¿s hospital course, the patient developed peritonitis. It was stated that the patient had a PD culture obtained (in the hospital) which had growth of fungus (bacteria unknown). Per the nurse, was initiated on antibiotic therapy in the hospital (details are unknown). Additionally, it was reported that 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 to a rehabilitation facility and continued hemodialysis on an outpatient basis. The nurse could not provide the exact cause for peritonitis. However, it was confirmed the patient did not have fluid leaks or any issu

  Patient problems: Peritonitis

  MAUDE report 50774196 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this peritoneal dialysis (PD) patient had an infection at the PD catheter (not an FME product). The catheter was removed and the patient transitioned to in-center hemodialysis (HD). 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 weakness and gastrointestinal (GI) upset. The patient was admitted. The patient had PD cultures obtained on (b)(6) 2026. The patient was diagnosed with peritonitis on (b)(6) 2026 when the PD culture returned positive for Corynebacterium jeikeium. The white blood cell (WBC) count was 2,389. During the hospitalization, the patient was administered intravenous (IV) Zosyn, Vancomycin, Ancef, and Zyvox (dose, frequency, and duration unknown). The PD catheter was removed (date not provided). The patient was permanently transitioned to hemodialysis (HD). The cause of the peritonitis is unknown. The patient did have a recent hospitalization on (b)(6) 2026-(b)(6) 2026 due to gastroenteritis which was unrelated to PD therapy or the use of any Fresenius Medical Care products.

  Patient problems: Muscle Weakness/Atrophy; Peritonitis; Unspecified Gastrointestinal Problem

  MAUDE report 50674122 ↗
• InjurySep 6, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50641037 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this peritoneal dialysis (PD) patient was hospitalized due to peritonitis. Additional information was provided through follow-up with the patient¿s peritoneal dialysis registered nurse (PDRN) and an email response provided by that PDRN. On (b)(6) 2026, the patient was experiencing severe abdominal pain. The pain began on (b)(6) 2026. The patient called 911 and was transported via ambulance to the emergency room (ER). The patient is in a wheelchair and cannot drive himself to the hospital. The patient was admitted to the hospital with a diagnosis of peritonitis. PD cultures were obtained on (b)(6) 2026. The patient was initiated on antibiotic therapy with intraperitoneal (IP) Fluconazole 200mg daily and Vancomycin 1750mg every 5th day to be completed on (b)(6) 2026. The patient¿s cultures were positive for methicillin-resistant Staphylococcus aureus (MRSA). The patient was discharged on (b)(6) 2026. The patient received a dose of Vancomycin on (b)(6) 2026 with the next dose on (b)(6) 2026. The suspected cause of the peritonitis event is a touch contamination event during an initial hospitalization for gallstones in which the patient was discharged on (b)(6) 2026

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 50544834 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  A peritoneal dialysis registered nurse "[(PD)RN]" reported a PD patient on continuous cyclic PD (CCPD) therapy utilizing the Liberty Select Cycler experienced peritonitis. There was no specific allegation that this event was related to a deficiency or malfunction of any Fresenius device(s) or product(s) in the initial reporting. Upon follow-up with the patient¿s PDRN, it was reported that this patient presented to the outpatient clinic on (b)(6) 2026 following abdominal pain, bloating with gas and turbid, discolored peritoneal effluent fluid. Peritoneal effluent fluid cultures and a white blood cell (WBC) count obtained in the outpatient clinic on (b)(6) 2026 presented with Staphylococcus epidermidis in the culture and a WBC count of 3925/mm3. The patient was diagnosed with peritonitis due to a break in asepsis during CCPD therapy on the Liberty Select Cycler at home. The clinic discovered the patient was reusing disposables during PD that are meant for one-time use. The patient was not hospitalized for this event and prescribed intraperitoneal (IP) Vancomycin at 2000 mg every four days for two weeks to address the infection at home. The patient is recovering from this event as he

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

  MAUDE report 50311574 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  A call was placed to customer support requesting assistance with cancelling this patient¿s Peritoneal Dialysis (PD) treatment. There were no reported issues with the Fresenius cycler. However, it was stated the patient was going to the hospital due to not feeling well. In additional follow-up, the patient¿s PD nurse confirmed that on (b)(6) 2026 the patient was hospitalized with symptoms of vomiting. The nurse stated the patient had a PD culture obtained (in the hospital) which had growth of vancomycin resistant enterococcus (VRE). Per the nurse, the patient was diagnosed with peritonitis and was initiated on antibiotic therapy utilizing intravenous (IV) Daptomycin (dosing not provided). The patient remained in the hospital at the time follow-up was performed. 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: Peritonitis; Vomiting

  MAUDE report 50310981 ↗
• MalfunctionAug 18, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50290624 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 50261611 ↗
• MalfunctionAug 13, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50244769 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  A nurse reported a patient with end stage renal disease (ESRD) on continuous cyclic peritoneal dialysis "[CC(PD)]" for renal replacement therapy (RRT) was hospitalized due to a PD related issue. No additional information was provided during intake. A follow-up response was received on (b)(6) 2026. Although the timeline is unclear, the patient was reportedly hospitalized on (b)(6) 2026 and was diagnosed with peritonitis. It appears the patient was treated with oral Vancomycin (dose, duration, frequency not provided) and discharged somewhere between (b)(6) 2026. he patient contacted the PDRN (date not provided), asking about an upcoming home therapy clinic visit on (b)(6) 2026. During the call, the patient reported an inability to walk due to weakness, and incontinence while ambulating. The PDRN asked the patient if he had completed his course of oral Vancomycin and the patient was unable to remember during the call. Additionally, the patient reported his lower extremities are still swollen and a fluid blister had formed and popped which was leaking clear fluid. The PDRN questioned the patient further, asking if he was taking his oral Furosemide daily (dosage not provided) instead of

  Patient problems: Fatigue; Muscle Weakness/Atrophy; Peritonitis; Swelling/ Edema

  MAUDE report 50229782 ↗
• InjuryAug 12, 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 due to 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 = >10,000 u/L) were collected, and the patient was formally admitted. The patient was diagnosed with peritonitis and was treated with intraperitoneal (IP) Vancomycin 1000 mg every 3-5 days (based on Vancomycin trough level), and Ceftazidime 1000 mg daily for 21 days. The patient¿s peritoneal effluent culture result returned positive for Klebsiella on (b)(6) 2026, and the patient¿s Vancomycin was discontinued. The patient was reportedly still experiencing abdominal discomfort on (b)(6) 2026 and the decision was made to remove the patient¿s PD catheter (not a Fresenius product) and place a hemodialysis (HD) catheter (not a Fresenius product). The patient was transitioned to HD without any

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50224847 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  A user facility clinic manager reported that the peritoneal dialysis (PD) patient had peritonitis. The doctor recommended removing the PD catheter but the patient did not have it removed before moving to (b)(6) on (b)(6). In additional follow-up call, the PD nurse manager confirmed that on (b)(6)2026 this patient was seen in the outpatient PD clinic with symptoms of abdominal pain. Per the nurse, the patient had a PD culture obtained (the same day) which had growth of group G streptococcus. As a result, the patient was initiated on intra-peritoneal (IP) antibiotics utilizing Vancomycin and Cefepime (dosing not provided) on an outpatient basis for peritonitis. Additionally, it was reported that the patient¿s doctor recommended removing the PD catheter. However, the patient declined. The patient continued PD 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 patient breach in aseptic technique due to patient not wearing a mask during PD exchange and not performing proper hand hygiene.

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 50223989 ↗
• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Peritonitis

  MAUDE report 50194374 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by a Peritoneal Dialysis (PD) nurse that this patient on PD was hospitalized with peritonitis and had the PD catheter (not a Fresenius product) to be removed. 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 initially seen in the outpatient PD clinic with symptoms of abdominal pain and PD catheter malfunction. Per the nurse, the patient had a PD culture obtained (the same day) which had growth of candida tropicalis. The nurse indicated that the patient was not able to receive intra-peritoneal (IP) antibiotics due to PD catheter malfunction. As a result, the patient was admitted into the hospital on (b)(6) 2026 for further medical management. The nurse confirmed that the patient underwent removal of the PD catheter and was transitioned to hemodialysis for renal replacement needs. The patient is receiving intravenous antibiotic therapy (details unknown) for peritonitis and 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

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 50131020 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  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 product. In additional follow-up, the patient¿s PD nurse confirmed that the patient was hospitalized on (b)(6)2026 with symptoms of abdominal pain and cloudy PD effluent. The nurse reported that the patient had a PD culture obtained in the hospital. However, the nurse indicated that the PD culture results were not available. The nurse stated the patient was diagnosed with peritonitis and is receiving antibiotic therapy while hospitalized (details are unknown). Additionally, the PD nurse reported that the patient underwent removal of the PD catheter (not a Fresenius product) and was transitioned to hemodialysis modality for renal replacement needs. The patient remained in the hospital when follow-up was performed. The nurse confirmed the patient did not have fluid leaks or any issues/malfunctions with Fresenius products in relation to the event. The nurse stated that the peritonitis was due to a patient breach in aseptic technique.

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50130229 ↗

Recalls under the same FDA submission

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

• 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