Liberty® 180111Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,716 adverse event reports that list this exact device (DI 00840861100972), received between Sep 19, 2014 and Jul 17, 2025 — classified as 126 deaths, 761 injuries, 828 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (512 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,716 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) DISCOVERED A FLUID LEAK FROM AN UNKNOWN LOCATION AFTER ENDING THE PATIENT'S PD TREATMENT. THE PDRN REPORTED RECEIVING ALARMS PRIOR TO THE LEAK BUT DOES NOT RECALL WHICH ALARMS. FLUID WAS DISCOVERED IN THE PUMP MODULE AREA AND 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 PDRN WAS ADVISED TO USE THE CYCLER FOR NEXT DAY'S TREATMENT AND TO CALL IF ISSUES CONTINUE. UPON FOLLOW UP, THE PDRN CONFIRMED THE REPORTED EVENT AND THAT 17 ALARMS WERE RECEIVED PRIOR TO THE LEAK. THE PDRN STATED NOT KNOWING WHICH ALARMS WERE PRESENT AND COULD NOT CONFIRM THE LOCATION OF THE FLUID LEAK. THE PDRN STATED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PDRN STATED THAT THE PATIENT WAS ABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT USING A DIFFERENT CYCLER. THE PDRN CONFIRMED THAT THE OTHER CYCLER IS PERFORMING WITHOUT REOCCURRENCE OF THE REPORTED EVENT. THE PDRN CONFIRMED THAT THE CYCLER SET WAS DISCARDED AND NOT AVAILABLE TO BE RETURNED TO THE MANUFAC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22534496 ↗
• MalfunctionFeb 13, 2025Overfill; Overfill

  THIS IS A REPORT OF A PERITONEAL DIALYSIS (PD) PATIENT WHO EXPERIENCED AN INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT COINCIDENT WITH PD THERAPY. A PD PATIENT EXPERIENCED A SCALE READING ERROR MESSAGE THAT OCCURRED IN DRAIN 1 OF 4. THE BIOMED TECHNICIAN (BMT)REPORTED THAT THE TREATMENT INFORMATION SHOWED THERE WAS AN OVERFILL ASSOCIATED WITH PD TREATMENT. THE OVERFILL EVENT WAS INDICATED DUE TO DRAIN 1 BEING 2589 ML, WHICH IS 217% OF THE 1194ML FILL VOLUME. AS A RESULT OF THE IIPV EVENT, THE TECHNICAL SUPPORT REPRESENTATIVE ADVISED THE BMT TO DISCONTINUE USE OF THE CYCLER. A NEW CYCLER WAS ISSUED. IN A FOLLOW UP, THE BMT VERIFIED THE OVERFILL EVENT AND SAID THERE WAS NO HARM, INTERVENTION OR ADVERSE EVENT DUE TO THE OVERFILL. THE CYCLER IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Increased Intra-Peritoneal Volume (IIPV)

  MAUDE report 21382123 ↗
• MalfunctionSep 12, 2023Sparking; Sparking

  A USER FACILITY NURSE MANAGER REPORTED TO FRESENIUS TECHNICAL SERVICES THAT A SPARK WAS OBSERVED ON THE BACK END OF THE LIBERTY SELECT CYCLER UPON PLUGGING THE POWER CORD INTO THE WALL OUTLET. THE CYCLER COULD NOT POWER ON. THERE WAS NO PATIENT INVOLVEMENT REGARDING THE REPORTED EVENT. A REPLACEMENT CYCLER WAS ISSUED. THE OLD CYCLER WAS SCHEDULED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE NURSE MANAGER. THE NURSE MANAGER WAS NOT PRESENT FOR THE EVENT AND THE AVAILABLE INFORMATION WAS OBTAINED FROM THE ACUTE NURSES. THERE WAS NO PATIENT INVOLVEMENT REGARDING THE REPORTED EVENT. A SPARK WAS OBSERVED ON THE BACK END OF THE CYCLER UPON PLUGGING THE POWER CORD INTO THE WALL OUTLET. THE CYCLER COULD NOT POWER ON. THERE WAS NO OBSERVED SMOKE, FLAME, ARCING, OR BURNING SMELL. THERE WAS NO ISSUE OBSERVED WITH THE WALL OUTLET PRIOR TO OR AFTER THE REPORTED EVENT. AT THE TIME OF FOLLOW-UP IT COULD NOT BE CONFIRMED WHETHER THE REPLACEMENT CYCLER WAS RECEIVED OR THE OLD CYCLER WAS PICKED UP AND RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17729380 ↗
• MalfunctionAug 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A NURSE FOR A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS TECHNICAL SUPPORT TO REPORT THE LIBERTY SELECT CYCLER ALARMED WITH AN M31 AIR DETECTED IN CASSETTE WARNING DURING DRAIN 4 OF 5. A FLUID LEAK WAS SUBSEQUENTLY DISCOVERED IN STEP 9 OF TREATMENT COMPLETE. FLUID WAS FOUND IN BOTH THE PUMP MODULE AREA AND ON THE EXTERNAL PORTION OF THE CASSETTE. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER TO DATE HAS NOT BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17629000 ↗
• MalfunctionFeb 10, 2023Smoking; Smoking

  A PERITONEAL DIALYSIS(PD) PATIENT REPORTED THAT THE CYCLER POWERED DOWN, HAD AN UNKNOWN ALARM, DISTORTED DISPLAY, AND ALSO SOME SMOKE WAS NOTICED. THE PATIENT STATED GETTING A RED ALARM. THE PATIENT THEN POWERED THE CYCLER OFF AND TURNED IT BACK ON AGAIN. THE SCREEN STARTED FLASHING THEN POWERED OFF. THE CYCLER STARTED SMOKING FROM THE HEATER TRAY. PATIENT WAS CONNECTED DURING THE EVENT. THE DISTORTED SCREEN OCCURRED IN AN UNKNOWN PHASE OF TREATMENT. TECHNICAL SERVICES ISSUED THE PATIENT A NEW CYCLER. IN A FOLLOW UP THE PATIENT'S PD NURSE VERIFIED THAT THE PATIENT DID NOT HAVE ANY HARM, ADVERSE EVENT OR INTERVENTION DUE TO THE BLANK SCREEN OR SMOKE. THE PATIENT RECEIVED A NEW CYCLER. THE COMPLAINT CYCLER IS AVAILABLE TO BE RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16353690 ↗
• MalfunctionJan 18, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT THE SCREEN OF A PATIENT¿S LIBERTY SELECT CYCLER WENT BLANK DURING POWER UP BEFORE THEIR PERITONEAL DIALYSIS (PD) TREATMENT. THE POWER CORD WAS PROPERLY CONNECTED IN BOTH ENDS AND CYCLER PLUGGED DIRECTLY INTO THE WALL OUTLET. THE CYCLER WAS REBOOTED, THE OK AND STOP KEYS LIT UP, HOWEVER THE SCREEN REMAINED BLANK. AT THAT POINT IN TIME, THE TECHNICAL SUPPORT REPRESENTATIVE ADVISED THE PATIENT TO DISCONTINUE USE OF THE CYCLER AND TO NOTIFY THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) OF THE EVENT. A REPLACEMENT CYCLER WAS ISSUED TO THE PATIENT. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. ADDITIONAL INFORMATION REQUESTED BUT HAS NOT BEEN OBTAINED. THE CYCLER WAS RETURNED TO THE MANUFACTURER AND A REPLACEMENT CYCLER WAS PROVIDED AND RECEIVED. 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 16195957 ↗
• DeathNov 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, FRESENIUS BECAME AWARE THIS PATIENT EXPERIENCED A CARDIAC ARREST WHILE UNDERGOING CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) THERAPY, AND LATER EXPIRED AT THE HOSPITAL. SUBSEQUENT ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION (E.G., DISCHARGE SUMMARY, ESRD DEATH NOTIFICATION, AUTOPSY REPORT, TREATMENT DATA, DEATH CERTIFICATE) HAVE THUS FAR PROVEN UNSUCCESSFUL.

  Patient problems: Cardiac Arrest

  MAUDE report 15740865 ↗
• MalfunctionNov 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY A REGISTERED NURSE (RN) THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK WHEN THE PATIENT UNSCREWED THE TUBING TO THE DRAIN LINE AFTER ENDING THEIR PD TREATMENT. THE RN REPORTED THAT THE PATIENT SHOULD HAVE BEEN EMPTY BUT THE CYCLER WAS STILL READING 1122ML DRAINED. THE CYCLER WOULD NOT ALLOW THE RN TO BYPASS. IT WAS REPORTED THAT A PLEASE CHECK PATIENT LINE AND DRAIN LINE MESSAGE OCCURRED IN DRAIN 1 OF 5 OF TREATMENT. THE PATIENT WAS ADVISED TO DISCONTINUE THE USE OF THEIR CYCLER AND FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15712429 ↗
• MalfunctionSep 26, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED TO FRESENIUS THAT FLUID WAS DISCOVERED ON THE INSIDE OF THE CASSETTE DOOR OF THE CYCLER AFTER ENDING A PERITONEAL DIALYSIS (PD) PATIENT'S TREATMENT. THE NURSE REPORTED THAT A HEATER BAG NOT DETECTED MESSAGE AND A PATIENT LINE (PL) IS BLOCKED MESSAGE WERE ENCOUNTERED DURING SETUP AND TREATMENT. THE NURSE CONFIRMED THE PATIENT COMPLETED TREATMENT ON THE CYCLER AND FLUID WAS FOUND AFTER THE COMPLETION OF TREATMENT. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE CYCLER REMAINS AT THE FACILITY AND HAS NOT BEEN UTILIZED SINCE THIS TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15486299 ↗
• DeathSep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, A REGISTERED NURSE (RN) REPORTED THAT THIS HOSPITALIZED PATIENT EXPIRED DURING DWELL 2 OF A PERITONEAL DIALYSIS (PD) TREATMENT WITH THE FRESENIUS CYCLER. THE NURSE INDICATED THE PATIENT¿S DEATH WAS NOT ASSOCIATED WITH THE PERFORMANCE OF THE CYCLER. AN ADDITIONAL FOLLOW-UP CALL WAS MADE TO THE REPORTING NURSE IN ATTEMPT TO GATHER MORE INFORMATION ABOUT THE NATURE OF THE EVENT. HOWEVER, THE NURSE WAS NOT ABLE TO PROVIDE SPECIFIC PATIENT DETAILS. THE NURSE STATED THE PATENT HAD SEVERAL UNSPECIFIED COMORBID CONDITIONS. THE NURSE CONFIRMED THE PATIENT EXPIRED ON (B)(6) 2022BUT REPORTED CAUSE OF DEATH AS UNKNOWN. HOWEVER, IT WAS STATED THE CYCLER WAS NOT RETUNED TO MANUFACTURER AND THE NURSE REITERATED THE DEATH WAS NOT RELATED TO THE PERFORMANCE OF THE FRESENIUS CYCLER. NO OTHER INFORMATION WAS PROVIDED OR AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15450944 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL REGISTERED NURSE REPORTED TO FRESENIUS TECHNICAL SERVICES THIS HOSPITALIZED PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLIC PD (CCPD) THERAPY ON A HOSPITAL PROVIDED LIBERTY CYCLER (HOME CYCLER UNKNOWN) EXPERIENCED AN INFECTION. THERE WAS NO SPECIFIC ALLEGATION THIS EVENT WAS DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS DEVICE(S) OR PRODUCT(S) IN THE INITIAL REPORTING. MULTIPLE ATTEMPTS WERE MADE TO ACQUIRE FURTHER DETAILS CONCERNING THIS ANONYMOUS PATIENT¿S INFECTION; HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED. IN THE INTAKE, IT WAS REPORTED THE PATIENT WAS HAVING DRAIN COMPLICATIONS DURING CCPD THERAPY ON THE HOSPITAL PROVIDED LIBERTY CYCLER DUE TO THIS REPORTED INFECTION; HOWEVER, THERE WAS NO INDICATION THE INFECTION WAS RELATED TO THE PERFORMANCE OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S).

  Patient problems: Unspecified Infection

  MAUDE report 15219321 ↗
• MalfunctionJun 22, 2022Overfill; Overfill

  THIS IS A REPORT OF A PATIENT WHO EXPERIENCED AN INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT DISCONTINUED TREATMENT DURING STAT DRAIN 4 DUE TO THE LARGE DRAIN. A REVIEW OF THE PATIENT¿S TREATMENT RECORDS IDENTIFIED THAT THE PATIENT DRAINED 4192 ML DURING STAT DRAIN 4 OF THE TREATMENT. THIS DRAIN VOLUME IS 210% THE PATIENT'S PRESCRIBED FILL VOLUME OF 2000 ML. AS A RESULT OF THE IIPV EVENT, THE TECHNICAL SUPPORT REPRESENTATIVE ADVISED THE PATIENT TO DISCONTINUE USE OF THE CYCLER AND TO NOTIFY THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) OF THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER, TO DATE HAS NOT BEEN PROVIDED.

  Patient problems: Abdominal Distention; Increased Intra-Peritoneal Volume (IIPV)

  MAUDE report 14778440 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL PERITONEAL DIALYSIS REGISTERED NURSE [(PD)RN] REPORTED TO FRESENIUS THIS 44-YEAR-OLD FEMALE PD PATIENT ON CONTINUOUS CYCLIC PD (CCPD) THERAPY ON THE LIBERTY SELECT CYCLER EXPERIENCED DYSPNEA FOLLOWING A PD TREATMENT WHILE HOSPITALIZED. THERE WAS NO SPECIFIC ALLEGATION THIS ADVERSE EVENT WAS DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S) IN THE INITIAL REPORTING. UPON FOLLOW UP WITH THE PATIENT¿S PDRN, IT WAS REPORTED THIS PATIENT WAS HOSPITALIZED ON (B)(6) 2022 FOR PNEUMONIA, AN EXACERBATION OF PREEXISTING CONGESTIVE HEART FAILURE, PLEURAL EFFUSIONS AND HYPOXEMIC RESPIRATORY FAILURE. IT WAS AFFIRMED THESE DIAGNOSES WERE ATTRIBUTED TO THE PATIENT¿S MULTIMORBIDITY AND DETERMINED TO BE UNRELATED TO PD THERAPY. IT WAS UNKNOWN IF THE PATIENT¿S SYMPTOMS REGARDING THESE DIAGNOSES OCCURRED DURING A HOME CCPD TREATMENT ON THEIR HOME CYCLER PRIOR TO HOSPITAL ADMISSION. THE PATIENT UNDERWENT A CCPD TREATMENT ON (B)(6) 2022, UTILIZING A HOSPITAL PROVIDED LIBERTY SELECT CYCLER WHILE ADMITTED. UPON COMPLETION OF THE PD TREATMENT ON THE MORNING OF (B)(6) 2022, THE PATIENT EXPERIENCED SEVERE DYSPNEA. THE HOSPITAL RAPID RESPONSE TEAM WAS ACTIVATED, AND THE PA

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure; Pleural Effusion; Pneumonia; Respiratory Failure

  MAUDE report 14682522 ↗
• MalfunctionJun 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED A FLUID LEAK IN THE PUMP MODULE AREA OF THE LIBERTY SELECT CYCLER AFTER ENDING THEIR PD TREATMENT. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. UPON FOLLOW UP, IT WAS CONFIRMED THAT THE PATIENT WAS ABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE CASSETTE USED FOR TREATMENT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER TO DATE HAS NOT BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14657997 ↗
• MalfunctionApr 14, 2022Fluid/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 A CYCLER AFTER THE PATIENT COMPLETED THEIR PD TREATMENT. THE PDRN REPORTED RECEIVING AN M21-10 INVALID SENSOR READING. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. UPON FOLLOW UP, THE PDRN CONFIRMED THAT THE PATIENT WAS ABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE CYCLER WAS REMOVED FROM SERVICE AND SUBSEQUENTLY REPLACED. THE CASSETTE USED BY THE PATIENT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER. THE CYCLER WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER TO DATE HAS NOT BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14111311 ↗
• MalfunctionApr 4, 2022Sparking; Sparking

  A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) REPORTED THAT THE PERITONEAL DIALYSIS (PD) PATIENT¿S CYCLER FELL, AND THE OUTLET CONNECTION BECAME LOOSE. THE PDRN STATED WHEN IT WAS PLUGGED IN FOR USE A SPARK OCCURRED. THE PATIENT WAS ADVISED TO DISCONTINUE THE USE OF THEIR CYCLER AND FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). A NEW CYCLER WAS ISSUED TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER; TO DATE HAS NOT BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14006183 ↗
• DeathMar 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A NURSE CONTACTED CUSTOMER SUPPORT AND REQUESTED A REPLACEMENT CYCLER REPORTING THAT AN UNKNOWN PATIENT PREVIOUSLY EXPERIENCED A MYOCARDIAL INFARCTION WHILE CONNECTED TO THE MACHINE. THERE WERE NO RECORDED ALLEGATIONS OF ANY MALFUNCTIONS OR PRODUCT ISSUES DIRECTLY RELATED TO THE REPORTED EVENT. THE NURSE INDICATED THE PATIENT SUBSEQUENTLY EXPIRED AFTER BEING DISCONNECTED FROM THE CYCLER. DETAILS SURROUNDING THE PATIENT¿S DEATH ARE UNKNOWN AND NO FURTHER INFORMATION IS AVAILABLE DESPITE MULTIPLE DUE DILIGENCE ATTEMPTS TO REACH THE REPORTING NURSE.

  Patient problems: Myocardial Infarction

  MAUDE report 13760240 ↗
• MalfunctionMar 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A REGISTERED NURSE (RN) REPORTED TO FRESENIUS THAT A FLUID LEAK WAS DISCOVERED ON THE INSIDE OF THE CASSETTE DOOR OF A USER FACILITY CYCLER AFTER ENDING A PERITONEAL DIALYSIS (PD) TREATMENT. THE RN REPORTED THAT THE CYCLER DISPLAYED MULTIPLE UNSPECIFIED ERRORS DURING TREATMENT AND THE TREATMENT WAS CANCELLED. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. THE RN WAS ADVISED TO DISCONTINUE THE USE OF THEIR. A NEW CYCLER WAS ISSUED TO THE PATIENT. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE RN STATED THE PATIENT COMPLETED TREATMENT ON ANOTHER FACILITY CYCLER. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE FACILITY HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND 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. THE CYCLER WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13638580 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO FRESENIUS THAT THIS PERITONEAL DIALYSIS (PD) PATIENT PASSED AWAY. THE PATIENT HAD A FUNGAL INFECTION AND DID NOT WANT TO HAVE THE PD CATHETER REMOVED RESULTING IN STOPPING OF DIALYSIS. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). THE PATIENT REPORTED CLOUDY PD EFFLUENT ON (B)(6) 2021 AND WAS SEEN AT THE PD CLINIC. A PD EFFLUENT CULTURE WAS OBTAINED, AND THE PATIENT WAS INITIATED ON EMPIRICAL ANTIBIOTICS (DRUG, ROUTE, DOSE, FREQUENCY, AND DURATION UNKNOWN). ON (B)(6) 2021 THE CULTURE RESULTED POSITIVE FOR FUNGAL PERITONITIS. IT WAS DETERMINED THE PATIENT WOULD REQUIRE SURGERY TO HAVE THE PD CATHETER PULLED (INTERNATIONAL SOCIETY OF PERITONEAL DIALYSIS RECOMMENDATION FOR FUNGAL PERITONITIS) AND THAT THE RECOVERY FROM THE PERITONITIS AND SURGERY WOULD BE EXTENSIVE. THE PATIENT¿S HEALTH WAS ALREADY GENERALLY FAILING AND DUE TO THEIR AGE, THE PATIENT AND THEIR GRANDDAUGHTER DECIDED NOT TO UNDERGO TREATMENT FOR THE FUNGAL PERITONITIS AND TO WITHDRAW FROM PERITONEAL DIALYSIS. ON (B)(6) 2021 THE PATIENT STOPPED ALL DIALYSIS TREATMENTS AND ENTERED INTO HOSPICE. ON (B)(6) 2021 THE PATIENT EXPIRED. THE

  Patient problems: Peritonitis

  MAUDE report 13043403 ↗
• MalfunctionNov 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT ENCOUNTERED A FLUID LEAK AFTER COMPLETING PD TREATMENT. THE PATIENT REPORTED THAT THERE WAS FLUID LEAKING FROM INSIDE THE CASSETTE DOOR OF THE CYCLER. FLUID WAS DISCOVERED IN THE PUMP MODULE AREA AND ON THE EXTERNAL OF THE CASSETTE. THE CAUSE OF THE LEAK IS UNKNOWN. UPON FOLLOW UP, THE PATIENT VERIFIED BEING TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED, AND CONFIRMED THE ABILITY TO COMPLETE PERITONEAL DIALYSIS TREATMENT USING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) IN THE ABSENCE OF THE CYCLER. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE CYCLER IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751570 ↗
• DeathOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO FRESENIUS BY A PERITONEAL DIALYSIS REGISTERED NURSE [(PD)RN] THAT THE PD PATIENT ON CONTINUOUS CYCLIC PD (CCPD) THERAPY ON THE LIBERTY SELECT CYCLER EXPIRED WHILE CONNECTED TO THE CYCLER. THERE WAS NO SPECIFIC ALLEGATION THIS EVENT WAS DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S) IN THE INITIAL REPORTING. UPON FOLLOW UP WITH THE PATIENTS PDRN, IT WAS REPORTED THIS PATIENT EXPIRED AT HOME ON (B)(6) 2021 DUE TO A SUDDEN CARDIAC ARREST. IT WAS STATED THE PATIENT HAD A SIGNIFICANT CARDIOVASCULAR DISEASE HISTORY THAT DIRECTLY ATTRIBUTED TO THE PATIENTS SUDDEN CARDIAC ARREST. EMERGENCY SERVICES WERE ACTIVATED, AND THE PATIENT WAS PRONOUNCED DECEASED IN HIS HOME. THE PATIENT WAS CONNECTED TO THE LIBERTY SELECT CYCLER AT THE TIME OF DEATH; HOWEVER, THE CYCLER SHOWED THE PATIENT COMPLETED THE TREATMENT AND THERE WERE NO ALARMS THROUGH THE COURSE OF THE TREATMENT. ADDITIONALLY, IT WAS CONFIRMED THE PATIENTS DEATH DUE TO A SUDDEN CARDIAC ARREST WAS UNRELATED TO PD THERAPY AND NOT DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S).

  Patient problems: Cardiac Arrest

  MAUDE report 12677077 ↗
• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A HOSPITAL NURSE CONTACTED FRESENIUS TECHNICAL SUPPORT FOR AIR DETECTED IN CASSETTE WARNINGS IN DRAIN 0 FOR A HOSPITALIZED PATIENT UTILIZING THE LIBERTY CYCLER. DURING THE CALL THE CYCLER MOVED FORWARD TO FILL 1 WITH NO FURTHER ALARMS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE REASON FOR THE PATIENT¿S HOSPITALIZATION IS UNKNOWN; HOWEVER, THERE IS NO ALLEGATION OF A DEVICE MALFUNCTION OR DEFICIENCY REPORTED FOR THE EVENT. THERE IS NO INDICATION OF A SERIOUS INJURY, PATIENT DEATH, OR OTHER ADVERSE EVENT RELATED TO A FRESENIUS PRODUCT OR OTHER ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 12408517 ↗
• InjuryAug 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERITONEAL DIALYSIS (PD) PATIENT WAS TAKEN TO THE EMERGENCY ROOM AFTER EXPERIENCING A SEIZURE DURING TREATMENT. THE LIBERTY CYCLER UTILIZED FOR THE TREATMENT WAS REGISTERED TO A FRESENIUS ACUTE FACILITY, HOWEVER, DETAILS ON THE HEALTH CARE PROVIDER, PATIENT, AND LOCATION OF THE EVENT WERE NOT REPORTED. IT IS UNKNOWN IF THE PATIENT OWNS FRESENIUS PD PRODUCTS. THERE WAS NO ALLEGATION THAT THE HOSPITALIZATION WAS RELATED TO THE USE OF A FRESENIUS DEVICE, DRUG, OR PRODUCT. MULTIPLE ATTEMPTS WERE MADE TO ACQUIRE ADDITIONAL INFORMATION, HOWEVER, A RESPONSE WAS NOT RECEIVED.

  Patient problems: Convulsion/Seizure

  MAUDE report 12341598 ↗
• MalfunctionJul 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) REPORTED THAT A FLUID LEAK WAS DISCOVERED DURING PERITONEAL DIALYSIS (PD) PATIENT¿S TREATMENT. THE FLUID WAS DISCOVERED IN THE PUMP MODULE AREA. THE PDRN REPORTED RECEIVING AIR DETECTED IN CASSETTE ALARMS PRIOR TO DISCOVERING THE FLUID LEAK. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. THE PDRN WAS ADVISED TO DISCONTINUE THE USE OF THEIR CYCLER. A NEW CYCLER WAS ISSUED TO THE CLINIC. UPON FOLLOW UP, THE PDRN CONFIRMED THE REPORTED EVENT OCCURRED DURING TREATMENT. THE PDRN STATED THEY RECEIVED MULTIPLE AIR DETECTED IN CASSETTE ALARMS DURING AN UNKNOWN PHASES OF TREATMENT. UPON CHECKING THE CASSETTE DOOR AFTER FINISHING THE TREATMENT THERE WAS FLUID LEAKING OUT ALL OVER THE DOOR AND THERE WAS FLUID LEAKING FROM THE EXTERNAL OF THE CASSETTE. THE PDRN CONFIRMED THAT THERE WERE NO OTHER FLUID LEAKS OBSERVED. THE CAUSE OF THE LEAK WAS UNKNOWN. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PDRN STATED THAT THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12240115 ↗
• MalfunctionJul 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A REGISTERED NURSE (RN) DISCOVERED A FLUID LEAK FROM THE CASSETTE DOOR OF THE CYCLER DURING STEP 9 AFTER ENDING THE PATIENT¿S PD TREATMENT. THE RN REPORTED RECEIVING M31 AIR DETECTED IN CASSETTE ALARMS DURING AN UNKNOWN PHASE AND CYCLE OF TREATMENT. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. THE FLUID LEAK DID COME IN CONTACT WITH THE CYCLER AND WAS DISCOVERED IN THE PUMP MODULE AREA. FLUID WAS NOT DISCOVERED ON THE EXTERNAL OF THE CASSETTE. THE RN WAS ADVISED TO DISCONTINUE THE USE OF THEIR CYCLER. A NEW CYCLER WAS ISSUED TO THE PATIENT. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE RN STATED THE PATIENT COMPLETED PERITONEAL DIALYSIS TREATMENT USING ANOTHER FACILITY CYCLER. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE FACILITY HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE LIBERTY CYCLER SET USED BY THE PATIENT WAS DISCARDED AND IS NO LONGER AVAILABLE TO BE RETURNED FOR PHYSICAL EVALUATION BY THE MAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12225223 ↗