Liberty 050-87215ARecalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00840861102709), received between Oct 11, 2024 and Jul 8, 2026 — classified as 20 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (21 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 41 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a peritoneal dialysis (PD) was diagnosed with peritonitis. Per the PD nurse, on (b)(6) 2026 the patient was seen in the outpatient PD clinic with symptoms of cloudy PD effluent. As a result, the patient had a PD culture obtained (the same day) which was positive for growth of the bacteria Klebsiella (species not provided). The patient was initiated on intra-peritoneal (IP) antibiotic therapy utilizing Cefepime (dose not provided). The patient continued PD with the same cycler, per nurse. 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 the peritonitis was due to patient breach in aseptic technique.

  Patient problems: Peritoneal effluent abnormal; Peritonitis

  MAUDE report 25753677 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, A PERITONEAL DIALYSIS REGISTERED NURSE "[(PD)RN]" REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THIS 60-YEAR-OLD FEMALE PD PATIENT ON CONTINUOUS CYCLIC PD (CCPD) THERAPY UTILIZING THE LIBERTY SELECT CYCLER WAS HOSPITALIZED WITH 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 CONDUCTED ON (B)(6) 2026 WITH THE PATIENT¿S PDRN, IT WAS REPORTED THAT THIS PATIENT WAS HOSPITALIZED ON (B)(6) 2026 FOLLOWING ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID NOTED AT HOME. PERITONEAL EFFLUENT FLUID CULTURES AND A WHITE BLOOD CELL (WBC) COUNT OBTAINED AND TESTED IN THE HOSPITAL ON (B)(6) 2026 PRESENTED WITH CORYNEBACTERIUM (SPECIES NOT REPORTED) IN THE CULTURE AND A WBC COUNT OF 6263/MM3. THE PATIENT WAS DIAGNOSED WITH PERITONITIS DUE TO A BREAK IN ASEPTIC TECHNIQUE DURING CCPD THERAPY ON THE LIBERTY SELECT CYCLER AT HOME. IT WAS EXPLAINED THAT THE PATIENT ADMITTED TO INTERMITTENTLY NOT WEARING A MASK OR WASHING HANDS DURING PD TREATMENTS. THE PATIENT WAS PRESCRIBED INTRAVENOUS (IV) VANCOMYCIN AND IV CEFTRIAXONE (DOSAGES AND FREQUENCIES NOT

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 25670348 ↗
• MalfunctionJun 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK ON THE INSIDE OF THE CASSETTE DOOR OF THEIR CYCLER AFTER ENDING THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DRAIN 1 OF TREATMENT AND THE TREATMENT WAS CANCELLED. FLUID WAS DISCOVERED IN THE PUMP MODULE AND ON THE EXTERNAL OF THE CASSETTE. THE CAUSE OF THE LEAK IS UNKNOWN. THE PATIENT WAS ADVISED TO DISCONTINUE THE USE OF THEIR CYCLER TO ALLOW IT TO DRY OUT UNTIL THE NEXT TREATMENT. UPON FOLLOW UP, IT WAS CONFIRMED THAT THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE CYCLER SET USED BY THE PATIENT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364436 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, DURING A FOLLOW-UP, A PERITONEAL DIALYSIS REGISTERED NURSE [(PD)RN] REPORTED TO FRESENIUS THIS PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLIC PD (CCPD) THERAPY UTILIZING THE LIBERTY SELECT CYCLER EXPERIENCED ABDOMINAL PAIN WITH DRAIN COMPLICATIONS AND SHE WAS ADVISED TO PRESENT TO THE HOSPITAL. 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 WAS HOSPITALIZED ON (B)(6) 2026 FOLLOWING ABDOMINAL PAIN AND DRAIN COMPLICATIONS DURING PD THERAPY. THE OUTPATIENT CLINIC HAS NOT RECEIVED DETAILS CONCERNING THE PATIENT¿S HOSPITAL COURSE AS SHE REMAINS ADMITTED AND DISCHARGE PAPERWORK WAS NOT YET BEEN RECEIVED. AS A RESULT, DIAGNOSTIC TESTING RESULTS AND DETAILS OF THE PATIENT¿S HOSPITAL COURSE WERE UNKNOWN. THE PATIENT WAS DIAGNOSED WITH PERITONITIS DUE TO A BREAK IN ASEPSIS DURING CCPD THERAPY ON THE LIBERTY SELECT CYCLER AT HOME. IT WAS BELIEVED THAT THE PATIENT WAS ABLE TO UNDERGO CCPD THERAPY ON A HOSPITAL PROVIDED CYCLER (UNKNOWN BRAND AND MODEL) FOR THE DURATION OF THE ADMISSION. TH

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 24746718 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO FRESENIUS THAT A PERITONEAL DIALYSIS (PD) PATIENT WAS HOSPITALIZED DUE TO AN INFECTED ¿CATHETER PORT¿ AND PERITONITIS. DURING FOLLOW-UP, THE PATIENT¿S PD REGISTERED NURSE (PDRN) REVEALED THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH COMPLAINTS OF ABDOMINAL PAIN AND DRAIN COMPLICATIONS. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (RESULTS UNAVAILABLE) WERE COLLECTED, AND THE PATIENT WAS FORMALLY ADMITTED. THE PATIENT WAS DIAGNOSED WITH A PD CATHETER (NOT A FRESENIUS PRODUCT) INFECTION, PERITONITIS, AND WAS TREATED WITH INTRAPERITONEAL (IP) VANCOMYCIN AND CEFEPIME (DOSAGES, DURATIONS, FREQUENCIES NOT PROVIDED). THE PATIENT¿S PERITONEAL EFFLUENT CULTURE RESULT RETURNED POSITIVE FOR BACILLUS CERUS ON (b)(6) 2026, AND THE PATIENT¿S NEPHROLOGIST ORDERED THE REMOVAL OF THE PATIENT¿S PD CATHETER, PLACEMENT OF A HEMODIALYSIS (HD) CATHETER (NOT A FRESENIUS PRODUCT), AND TRANSITION TO HD. AS A RESULT, THE PATIENT¿S ANTIBIOTICS WERE CHANGED TO INTRAVENOUS (IV) ADMINISTRATION, AND THE PATIENT TOLERATED THE TRANSITION TO HD WITHOUT ANY KNOWN ISSUES. THE PATIENT IS RECOVERING FROM THE SERIOUS ADVERSE EVENTS AND REMAINED HOSPITALIZED AS OF (b)(6) 2026. THE PDRN ATTRIBU

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 24670928 ↗
• MalfunctionMar 4, 2026Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT REPORTED A FLUID LEAK ASSOCIATED WITH PD TREATMENT. THERE WAS AN AIR DETECTED IN CASSETTE WARNING DURING DRAIN 2 OF 4 OF PD TREATMENT. THE PATIENT CANCELLED TREATMENT AND FLUID WAS SEEN COMING FROM THE PATIENT'S CATHETER. THERE WAS FLUID IN THE PUMP MODULE AREA OF THE CYCLER AND ON THE EXTERNAL PART OF THE CASSETTE. IN A FOLLOW UP, THE PATIENT'S PD NURSE VERIFIED THE FLUID LEAK EVENT AND SAID THERE WAS NO HARM, INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THE LEAK. THERE WAS NO CATHETER LEAK. THE ORIGIN OF THE LEAK WAS NOT DETERMINED. THE PATIENT LET THE CYCLER DRY OUT AND HAS BEEN USING IT SINCE. THE CYCLER SET IS NOT AVAILABLE TO RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24513799 ↗
• MalfunctionFeb 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK DURING DRAIN 2 OF THEIR PD TREATMENT. THE PATIENT REPORTED NOT RECEIVING AN ALARM PRIOR TO THE LEAK. FLUID WAS DISCOVERED IN THE PUMP MODULE AREA AND ON THE EXTERNAL OF THE CASSETTE. FLUID LEAKED FROM A POSSIBLE HOLE IN THE BAG. THE CAUSE OF THE LEAK IS UNKNOWN. THE PATIENT WAS ASSISTED WITH CANCELLING TREATMENT. THE PATIENT WAS ALSO ADVISED TO WIPE DOWN THE CYCLER AND LET IT DRY AND TO FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE PATIENT CONFIRMED THE REPORTED FLUID LEAK OCCURRED ON THE CASSETTE AND FLUID WAS FOUND INSIDE THE CASSETTE DOOR. THERE WERE NO HOLES OR FLUID LEAKS ON ANY OF THE SOLUTION OR DRAIN BAGS. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT SKIPPED THE REMAINDER OF TREATMENT IN THE ABSENCE OF THE CYCLER. THE PATIENT LET THE CYCLER DRY AND IS CONTINUING WITH PERITONEAL DIALYSIS ON THE CYCLER WITHOUT ISSUE AND WITHOUT REOCCURRENCE OF THE REPORTED EVENT. THE PATIENT CONFIRMED THAT THE CYCLER SET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472519 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  ON (b)(6) 2026 DURING FOLLOW-UP, FRESENIUS BECAME AWARE 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 PERITONITIS ON FIVE SEPARATE OCCASIONS. THIS COMPLAINT FILE WILL ADDRESS THE SECOND EPISODE OF PERITONITIS. FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE (PDRN) CONFIRMED THE PATIENT PRESENTED TO THE OUTPATIENT HOME DIALYSIS CLINIC ON (b)(6) 2025 WITH COMPLAINTS OF CLOUDY PERITONEAL EFFLUENT FLUID. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (WBC = 323 /MM3, POLYMORPHS = 93%) WERE COLLECTED, AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) VANCOMYCIN 1000 MG EVERY FIVE DAYS FOR 14 DAYS. THE PATIENT¿S PERITONEAL EFFLUENT CULTURE RESULT RETURNED POSITIVE FOR ENTEROCOCCUS FAECALIS, AND THE PATIENT¿S ANTIBIOTIC WAS DISCONTINUED (SUBTHERAPEUTIC) AND REPLACED WITH LINEZOLID 600 MG TWICE DAILY (ROUTE AND DURATION NOT PROVIDED). THE PATIENT HAS RECOVERED FROM THE SERIOUS ADVERSE EVENTS AND COMPLETED HIS ANTIBIOTIC COURSE. THE PATIENT CONTINUED TO UNDERGO CCPD THERAPY

  Patient problems: Peritoneal effluent abnormal; Peritonitis

  MAUDE report 24339425 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS REGISTERED NURSE [(PD)RN] REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THIS PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLIC PD (CCPD) THERAPY UTILIZING THE LIBERTY SELECT CYCLER WAS HOSPITALIZED WITH 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 WAS HOSPITALIZED ON (B)(6) 2025 FOLLOWING ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID NOTED AT HOME. PERITONEAL EFFLUENT FLUID CULTURES AND A WHITE BLOOD CELL (WBC) COUNT OBTAINED AND TESTED IN THE HOSPITAL ON (B)(6) 2025 PRESENTED WITH KLEBSIELLA PNEUMONIAE IN THE CULTURE AND A WBC COUNT OF APPROXIMATELY 6000/MM3 (EXACT COUNT NOT REPORTED). THE PATIENT WAS DIAGNOSED WITH PERITONITIS DUE TO A BREAK ASEPTIC TECHNIQUE DURING CCPD THERAPY ON THE LIBERTY SELECT CYCLER ART HOME. THE PATIENT WAS PRESCRIBED INTRAPERITONEAL (IP) VANCOMYCIN AT 2000 MG AND IP CEFTAZIDIME AT 2000 MG (FREQUENCIES NOT REPORTED) TO ADDRESS THE INFECTION WHILE HOSPITALIZED. THE PATIENT HAS BEEN ABLE TO UNDERGO CCPD THERAPY ON A HOSPITAL-PROV

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 23959846 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT HAD PERITONITIS. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE (PDRN). THE PATIENT WAS SEEN IN THE PD CLINIC ON (B)(6) 2025 (NO SYMPTOMS PROVIDED). A PD EFFLUENT CULTURE WAS OBTAINED. THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS INITIATED ON ANTIBIOTIC THERAPY PER THE CLINIC¿S ALGORITHM (DRUG, DOSE, FREQUENCY, AND DURATION NOT PROVIDED). THE CULTURE RESULTED POSITIVE FOR GRAM-NEGATIVE BACILLI (NO ORGANISM OR SPECIES PROVIDED). THE PATIENT WAS NOT HOSPITALIZED FOR THIS PERITONITIS EVENT. THE PATIENT HAD A RECHECK OF WHITE CELL COUNT ON (B)(6) 2025 WHICH WAS WITHIN NORMAL LIMITS (NO VALUE PROVIDED) INDICATING THE PERITONITIS HAD CLEARED. THE PDRN STATED THE CAUSE OF THE PATIENT¿S PERITONITIS IS UNKNOWN. THE PATIENT WAS RECENTLY HOSPITALIZED (DATES NOT PROVIDED) FOR A SEIZURE WHICH WAS NOT RELATED TO DIALYSIS OR THE USE OF ANY FRESENIUS DEVICE, DRUG, OR PRODUCT. THE PATIENT STATED THE PERITONITIS COULD HAVE BEEN ACQUIRED IN THE HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Peritonitis

  MAUDE report 23793688 ↗
• MalfunctionNov 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS PATIENT (PT) REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT THEY HAD A FLUID LEAK. THE PATIENT WAS CONNECTED DURING INCIDENT. FLUID WAS FOUND ON THE HEATER TRAY. FLUID LEAKED FROM HEATER BAG (HB) CONNECTION. SUPPLY BAGS (SB) ARE HANGING. ALL CONNECTIONS ARE SECURELY CONNECTED. ALL CONES ARE BROKEN. THE PATIENT LINE (PL) DID PRIME ALL THE WAY TO THE END. HB WAS NOT EMPTY. UNUSED LINES WERE CLAMPED. THE ISSUE OCCURRED DWELL 3 OF 3. PT WAS CONNECTED DURING INCIDENT; FLUID LEAKED FROM HB AND THE TUBING CONNECTION. PER PT THE CONNECTION WAS SECURELY CONNECTED. THERE WERE ALARMS/WARNINGS PRIOR TO LEAK ¿ M31 AIR DETECTED IN CASSETTE WARNING OCCURRED PRIOR THE FLUID LEAK. UPON FOLLOW UP, THE PATIENT¿S PDRN STATED THE PATIENT DID NOT INFORM HER OF THE ISSUE. THE PDRN HAS NOT BEEN IN CONTACT WITH THE PATIENT SINCE THE INCIDENT AND DOES NOT KNOW THE CURRENT STATUS OF THE PATIENT. THERE WAS NO REPORTED PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, TO DATE, HAS NOT BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23624550 ↗
• MalfunctionNov 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK ON THE TUBING AFTER ENDING THEIR PD TREATMENT. THE PATIENT OPENED THE CASSETTE DOOR AND NOTICED FLUID LEAKING FROM THE LINES BUT DID NOT SEE WHERE IT CAME FROM. THE PATIENT REPORTED NOT RECEIVING AN ALARM PRIOR TO THE LEAK. FLUID WAS NOT DISCOVERED IN THE PUMP MODULE AREA OR ON THE EXTERNAL OF THE CASSETTE. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. THE CYCLER SET HAS BEEN DISCARDED SINCE THIS OCCURRED IN THE MORNING WHEN THE PATIENT WAS REMOVING THE SUPPLIES. THE PATIENT WANTED TO KNOW IF IT'S SAFE TO CONTINUE USING THE CYCLER SINCE NO PHYSICAL FLUID WAS FOUND INSIDE THE CASSETTE COMPARTMENT. THE PATIENT WAS ADVISED TO CONTINUE THE USE OF THEIR CYCLER. UPON FOLLOW UP, THE PDRN STATED THEY HAVE NOT BEEN MADE AWARE OF THE EVENT, HOWEVER, CONFIRMED THE PATIENT HAS NOT REPORTED DEVELOPMENT OF ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PDRN VERIFIED PER TREATMENT DATA THAT THE PATIENT COMPLETED TREATMENT USING THE CYCLER AND NEW SUPPLIES. THE PATIENT HAS BEEN PERFORMING SUBSEQUENT TREA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513183 ↗
• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 FOR PERITONITIS. FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE (PDRN) CONFIRMED THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2025 WITH COMPLAINTS OF ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (RESULTS UNAVAILABLE) WERE COLLECTED, AND THE PATIENT WAS ADMITTED. THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND WAS TREATED WITH (IP) VANCOMYCIN 2000 MG EVERY 5 DAYS, AND CEFTAZIDIME 1500 MG DAILY FOR 14 DAYS. THE PATIENT¿S PERITONEAL EFFLUENT CULTURE RESULT RETURNED POSITIVE FOR KOCURIA RHIZOPHILA ON (B)(6) 2025, AND THE PATIENT¿S CEFTAZIDIME WAS DISCONTINUED. THE PATIENT CONTINUED TO UNDERGO WHILE HOSPITALIZED WITHOUT ANY REPORTED ISSUES AND WAS DISCHARGED HOME IN STABLE CONDITION ON (B)(6) 2025. THE PATIENT HAS RECOVERED FROM THE SERIOUS ADVERSE EVENTS AND CONTINUES TO UNDERGO CCPD THERAPY AT HOME UTILIZING THE SAME LIBERTY SELECT CYCLER WITHOUT REPORTED ISSUES. THE PDRN ATTRIBUTED CAUSALIT

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 23341423 ↗
• MalfunctionOct 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK ON THE PATIENT LINE DURING FILL 1 OF 3 OF THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING A FILLING SLOWLY ALARM DURING FILL 1 OF 3 OF TREATMENT PRIOR TO THE LEAK AND THE TREATMENT WAS CANCELLED. THE PATIENT DID NOT SEE A HOLE OR TEAR IN THE LINE. TECHNICAL SUPPORT ASSISTED THE PATIENT TO RE-SETUP WITH ALL NEW SUPPLIES AND THEN EXPERIENCED DRAIN LINE IS BLOCKED AND HEATER BAG NOT DETECTED ALARMS DURING STEP 3 OF SETUP. UPON FOLLOW UP, THE PDRN STATED THEY HAVE NOT BEEN MADE AWARE OF THE EVENT, HOWEVER, CONFIRMED THE PATIENT HAS NOT REPORTED DEVELOPMENT OF ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23201855 ↗
• MalfunctionAug 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT REPORTED THE CYCLER PROMPTED WITH M31 - AIR DETECTED IN CASSETTE WARNINGS DURING FILL 5 OF 5 OF TREATMENT. A FLUID LEAK WAS DISCOVERED LEAKING FROM THE PATIENT LINE. FLUID WAS NOT DISCOVERED IN THE PUMP MODULE AREA OR OR ON THE EXTERNAL OF THE CASSETTE. THE PATIENT STATED WHEN THE CYCLER WARNINGS FIRST OCCURRED THE PATIENT TOUCHED THE PATIENT LINE AND IT FELT A LITTLE BIT WET AND THAT WAS IT. THE CYCLER WARNINGS OCCURRED PRIOR TO THE LEAK. THE PATIENT WAS ADVISED TO RE-SETUP THE CYCLER WITH ALL NEW SUPPLIES FOR THE NEXT TREATMENT AND TO CONTACT PD SUPPORT IF ANY ISSUES OCCURRED. UPON FOLLOW-UP, THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) CONFIRMED THE PATIENT'S REPORTED FLUID LEAK EVENT AND STATED A TUBING LEAK WAS OBSERVED FROM A TUBING LINE OUTSIDE THE CASSETTE DOOR. FLUID DID NOT COME IN CONTACT WITH THE CYCLER AND NO FLUID WAS NOTED WITHIN THE PUMP MODULE AREA, AND THE CASSETTE REMAINED DRY. THE PDRN STATED THE PATIENT WAS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED AND WAS ABLE TO DRAIN MANUALLY AND COMPLETED PERITONEAL DIALYSIS TREATMENT ON THE NIGHT OF THE REPORTED EVENT. THE PATIENT DID NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22800706 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS (PD) PATIENT CONTACT REPORTED TO FRESENIUS CUSTOMER SUPPORT THAT A PATIENT IS IN THE HOSPITAL AND THEY THINK HE MAY HAVE AN INFECTION IN THE CATHETER TUBE. 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) 2025. NO SYMPTOMS WERE REPORTED. THE PATIENT HAD PD CULTURES OBTAINED. THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS INITIATED ON ANTIBIOTICS WITH INTRAPERITONEAL (IP) VANCOMYCIN AND CEFTAZIDIME (DOSE, FREQUENCY, AND DURATION UNKNOWN). THE CULTURES WERE POSITIVE FOR GROWTH WITH PSEUDOMONAS AERUGINOSA. THE PATIENT¿S PD CATHETER WAS PULLED (DATE UNKNOWN) AND THE PATIENT WAS TRANSITIONED TO HEMODIALYSIS (HD). IT IS UNKNOWN WHAT ANTIBIOTIC THERAPY THE PATIENT IS COMPLETING WHILE ON HD. NO DISCHARGE DATE WAS NOTED IN THE PATIENT¿S RECORDS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN.

  Patient problems: Peritonitis

  MAUDE report 22671281 ↗
• MalfunctionJul 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS NURSE (PDRN) DISCOVERED A FLUID LEAK ON THE INSIDE OF THE CASSETTE DOOR OF THE CLINIC CYCLER AFTER ENDING A PATIENT¿S PD TREATMENT. IT WAS REPORTED THAT THE SUPPLIES WERE CONNECTED CORRECTLY AND FLUID WAS DISCOVERED ON THE BACK OF THE CASSETTE. FLUID WAS NOT DISCOVERED IN THE PUMP MODULE AREA. FLUID LEAKED FROM A SMALL HOLE ON THE BACK OF THE CASSETTE. THE CAUSE OF THE LEAK IS UNKNOWN. UPON FOLLOW UP, THE PDRN STATED THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED. STATED THAT THE PATIENT WAS PRESCRIBED PROPHYLACTIC ANTIBIOTICS. CONFIRMED THAT DESPITE THE PROPHYLACTIC ANTIBIOTICS, THERE WERE NO SYMPTOMS, ADVERSE EVENTS, OR INJURIES REQUIRING MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE CYCLER SET USED IS AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22441258 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REGISTERED NURSE (RN) REPORTED TO FRESENIUS THAT THIS PATIENT HAD BEEN HOSPITALIZED DUE TO PERITONITIS. THE NURSE DID NOT RECALL ANY ADDITIONAL INFORMATION REGARDING THE EVENT OR THE PATIENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE ACUTE CLINIC WAS UNSUCCESSFUL.

  Patient problems: Peritonitis

  MAUDE report 22337645 ↗
• MalfunctionJun 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK ON THE INSIDE OF THE CASSETTE DOOR OF THEIR CYCLER AFTER ENDING THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DRAIN 2 OF 5 OF TREATMENT AND THE TREATMENT WAS CANCELLED. FLUID WAS DISCOVERED IN THE PUMP MODULE AREA AND ON THE EXTERNAL OF THE CASSETTE. THE CAUSE OF THE LEAK IS UNKNOWN. THE PATIENT WAS ADVISED TO DISCONTINUE THE USE OF THEIR CYCLER FOR THE NIGHT TO ALLOW IT TO DRY OUT. ADDITIONAL INFORMATION REQUESTED BUT HAS NOT BEEN OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196565 ↗
• MalfunctionMay 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT REPORTED THE CYCLER PROMPTED WITH MULTIPLE M31 - AIR DETECTED IN CASSETTE WARNINGS DURING DRAIN 1 OF 4 OF TREATMENT. FLUID WAS SEEN IN THE CASSETTE DOOR. THE FILM ON THE BACK OF THE CASSETTE DOOR WAS LOOSE. THE PATIENT WAS TO RE-SETUP THE CYCLER WITH NEW SUPPLIES AND DRAIN IN DRAIN 0. UPON FOLLOW UP, THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) CONFIRMED THE REPORTED EVENT. THE PDRN STATED FLUID WAS NOTED FOLLOWING THE REPORTED M31 AIR DETECTED IN CASSETTE WARNING CYCLER ALARMS AND DURING STEP 9 OF TREATMENT AS TREATMENT WAS CANCELLED. THE PATIENT CANCELLED TREATMENT AND FOUND FLUID IN THE PUMP MODULE AREA AND ON THE EXTERNAL OF THE CASSETTE. THE FILM ON THE BACK OF THE CASSETTE WAS LOOSE BUT A HOLE WAS NOT NOTED. THE CAUSE OF THE FLUID LEAK WAS UNKNOWN. THE PATIENT CONFIRMED THERE WERE NO SYMPTOMS, ADVERSE EVENTS, OR INJURIES REQUIRING ANY OTHER MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PDRN STATED THE PATIENT WAS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED, AND STATED THE PATIENT CONTACTED THE ON-CALL NURSE FOR ASSISTANCE AND COMPLETED TREATMENT USING THE CYCLER AFTER R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944783 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REGISTERED NURSE (RN) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A PERITONEAL DIALYSIS (PD) PATIENT WAS DIAGNOSED WITH PERITONITIS. THE CAUSE WAS REPORTEDLY UNKNOWN. THE RN SAID THE PATIENT CONTINUED TO COMPLETE PD TREATMENTS. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: Peritonitis

  MAUDE report 21902759 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) REPORTED TO FRESENIUS CUSTOMER SUPPORT THAT A PATIENT HAS PERITONITIS AND IS IN THE HOSPITAL AT THIS TIME. THE PATIENT GOT THE INFECTION ON (B)(6) AND STILL HAS IT. THE PATIENT WILL BE ON ANTIBIOTICS FOR 14 DAYS. THE PATIENT STILL HAS THE PD CATHETER (NOT A FRESENIUS DEVICE). FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE (PDRN) CONFIRMED THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2025 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 ADMITTED. THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND WAS TREATED WITH INTRAPERITONEAL (IP) VANCOMYCIN AND FORTAZ FOR 14 DAYS. THE PATIENT¿S PERITONEAL EFFLUENT CULTURE RESULT RETURNED POSITIVE FOR STAPHYLOCOCCUS AUREUS ON (B)(6) 2025, AND THE PATIENT'S FORTAZ WAS DISCONTINUED. THE PATIENT HAS RECOVERED FROM THE SERIOUS ADVERSE EVENTS AND CONTINUED TO UNDERGO CCPD THERAPY WHILE HOSPITALIZED. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025 IN STABLE CONDITION, AND RESUMED UTILIZING THE SAME LIBERTY SELECT CYCLER WITHOUT ANY REPORTED ISSUES. THE PDRN

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 21529229 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PERITONEAL DIALYSIS (PD) PATIENT WAS HOSPITALIZED ON (B)(6) 2025 DUE TO PERITONITIS. THE PATIENT UNDERWENT A PD CATHETER (NOT A FRESENIUS PRODUCT) REMOVAL. THE PATIENT WAS REPORTED TO BE COMPLETING TEMPORARY IN-CENTER HEMODIALYSIS (HD). ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PD CLINIC. THE CLINIC HAD NOT RECEIVED THE PATIENT¿S HOSPITAL RECORDS, AND THEREFORE DID NOT HAVE INFORMATION PERTAINING TO THE DATES OF HOSPITALIZATION, CULTURE RESULTS, OR ANTIBIOTIC TREATMENT. IT WAS CONFIRMED THAT THE PATIENT DID HAVE THE PD CATHETER REMOVED (UNKNOWN DATE) AND THAT THE PATIENT IS COMPLETING IN-CENTER HD. IT WAS ALSO CONFIRMED THAT THERE WERE NO REPORTED CASSETTE LEAKS OR OTHER ISSUES WITH ANY FRESENIUS PRODUCTS AT THE TIME OF THE PERITONITIS DIAGNOSIS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Peritonitis

  MAUDE report 21504497 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO FRESENIUS 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 ADMITTED FOR PNEUMONIA (SPECIFICS UNKNOWN). WHILE HOSPITALIZED, THE PATIENT CONTRACTED PERITONITIS (SPECIFICS UNKNOWN) WHILE PERFORMING CCPD THERAPY AND REPORTEDLY WITHDREW FROM RRT THERAPY ON (B)(6) 2025. IT APPEARS THE PATIENT ENTERED SOME FORM OF PALLIATIVE CARE AND EXPIRED ON (B)(6) 2025. SUBSEQUENT ATTEMPTS TO OBTAIN ADDITIONAL CLINICAL INFORMATION (E.G., DEATH CERTIFICATE, ESRD DEATH NOTIFICATION, CAUSALITY, TREATMENT RECORDS, DISCHARGE SUMMARY) WERE UNSUCCESSFUL.

  Patient problems: Peritonitis; Pneumonia

  MAUDE report 21241780 ↗
• MalfunctionJan 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED A FLUID LEAK FROM THE HEATER BAG (HB) DURING DWELL 4 OF 4 OF TREATMENT. AN AIR DETECTED IN CASSETTE ALARM OCCURRED SEVERAL TIMES DURING DWELL 4 OF 4 PRIOR TO THE LEAK. THE PATIENT STATED THE HB WAS SECURELY CONNECTED BUT WHEN THE HB WAS LIFTED UP THERE WAS A PUDDLE OF FLUID ON THE HEATER TRAY (HT). THERE WERE NO HOLES FOUND IN THE HB. THE PATIENT WAS ADVISED TO FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). UPON FOLLOW UP, THE PATIENT CONFIRMED THE REPORTED EVENT AND THAT FLUID HAD LEAKED ONTO THE FLOOR. THE PATIENT CONFIRMED THAT THE FLUID WAS NOT CONDENSATION. THE PATIENT CHECKED THE CONNECTION TO THE CYCLER SET WITH A PATIENT CONTACT AND BOTH FOUND THE CONNECTION TO BE SECURED PROPERLY. THERE WAS NO FLUID OR MOISTURE FOUND WITHIN THE CYCLER DOOR. THE PATIENT COULD NOT CONFIRM WHERE THE FLUID LEAK ORIGINATED FROM. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT COULD NOT PERFORM THE LAST FILL AND BYPASSED TO PERFORM A STAT DRAIN IN THE ABSENCE OF THE CYCLER. THE PATIENT IS CONTINUING WITH PERITONEAL DIALYSIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21234978 ↗

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