Liberty® PDx 180237Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00840861100989), received between Jan 22, 2018 and Sep 15, 2022 — classified as 2 deaths, 8 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 THIS PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS TECHNICAL SUPPORT FOR A REMOVE INCORRECT CASSETTE AND INSERT CORRECT ONE MESSAGE RECEIVED FOR THE LAST TWO TREATMENTS UTILIZING THE LIBERTY SELECT CYCLER. THE PATIENT WAS UNABLE TO COMPLETE THE TREATMENTS. A REPLACEMENT CYCLER WAS ISSUED. THE PATIENT CONFIRMED THEY HAD SUPPLIES FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) AND THAT THEY WERE TRAINED ON HOW TO COMPLETE CAPD. ADDITIONAL INFORMATION WAS PROVIDED BY THE PATIENT¿S PD NURSE. ON (B)(6) 2022 THE PATIENT WAS INSTRUCTED BY THE CLINIC TO GO TO THE EMERGENCY ROOM (ER) DUE TO LOW SODIUM LEVELS (VALUES NOT PROVIDED). THE PATIENT WAS ADMITTED FOR HYPONATREMIA AND DISCHARGED ON 06/SEP/2022. THE PATIENT WAS NOT IN ACTIVE TREATMENT AT THE TIME OF ADMISSION. ATTEMPTS TO OBTAIN FURTHER INFORMATION RELATED TO THIS EVENT WERE UNSUCCESSFUL.

  Patient problems: Hyponatremia

  MAUDE report 15433005 ↗
• MalfunctionDec 16, 2021Fluid/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 FILL 1 OF 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 PATIENT CONFIRMED THAT THE SOLUTION DID GET INTO THE CYCLER. 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. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE PATIENT STATED IT IS UNKNOWN WHERE THE FLUID LEAK OCCURRED. 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 CASSETTE USED BY THE PATIENT 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 13021856 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FRESENIUS BECAME AWARE THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] FOR RENAL REPLACEMENT THERAPY (RRT) WAS TAKEN TO THE HOSPITAL VIA EMERGENCY MEDICAL SERVICES (EMS) ON (B)(6) 2021. FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE (PDRN) REVEALED THE PATIENT WAS EVALUATED THE PATIENT ON (B)(6) 2021 DURING THEIR MONTHLY APPOINTMENT WHERE THEY WERE DOING WELL. ADDITIONALLY ON (B)(6) 2021, THE PATIENT¿S SPOUSE REPORTED THEY WERE FEELING GREAT AND WORKING IN THE GARDEN MOST OF THE DAY. HOWEVER, ON THE MORNING OF (B)(6) 2021 THE PATIENT WAS DISCOVERED SEMI-UNCONSCIOUS AND COVERED IN VOMIT. THE SPOUSE CLEANED THE PATIENT, CALLED EMERGENCY MEDICAL SERVICES (EMS) AND COLLECTED A SAMPLE OF PERITONEAL EFFLUENT FLUID (MURKY). EMS TRANSPORTED THE PATIENT TO THE HOSPITAL, AND THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (WBCS ELEVATED, RESULT UNAVAILABLE) WAS OBTAINED, AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) ANTIBIOTICS (DRUGS, DOSAGES, FREQUENCY, DURATION UNAVAILABLE), AND THEIR MENTATION BEGAN TO IMPROVE. ON (B)(6) 2021, TH

  Patient problems: Loss of consciousness; Peritonitis; Vomiting

  MAUDE report 11877941 ↗
• InjuryMar 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT HAS BEEN INSTILLING ANTIBIOTICS VIA CAPD DAILY WITH NO ISSUES. TECHNICAL SUPPORT DISCUSSED POSSIBLE INCREASED FIBRIN PRODUCTION DUE TO A KNOWN INFECTION THE PATIENT IS BEING TREATED FOR AS WELL AS CONSTIPATION. UPON FOLLOW-UP WITH THE PD REGISTERED NURSE (PDRN) REVEALED THE PATIENT WAS SEEN IN THE PD CLINIC FOR A REPORT OF CLOUDY PD EFFLUENT. THE PATIENT DID NOT REPORT ANY PHYSICAL SYMPTOMS. A PD EFFLUENT CULTURE WAS OBTAINED, AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS INITIATED ON ANTIBIOTIC THERAPY. THE PATIENT WAS PRESCRIBED INTRAPERITONEAL (IP) GENTAMYCIN DAILY TO BE INSTILLED WITH A MANUAL EXCHANGE FOR A 6-HOUR DWELL (DOSE AND DURATION NOT PROVIDED). THE PD EFFLUENT CULTURE RESULTED POSITIVE FOR PSEUDOMONAS LUTEOLA, A GRAM-NEGATIVE AEROBIC BACILLUS. THE PATIENT DID NOT REQUIRE HOSPITALIZATION FOR THE EVENT. THE CAUSE OF THE PERITONITIS WAS NOT DETERMINED; HOWEVER, THE PDRN REPORTED THERE WAS MOST LIKELY A BREACH IN ASEPTIC TECHNIQUE BASED ON THE ORGANISM. THERE WAS NO REPORT OF A CASSETTE LEAK OR OTHER ISSUE RELATED TO THE LIBERTY PDX CYCLER.

  Patient problems: Peritonitis

  MAUDE report 11564109 ↗
• MalfunctionNov 13, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY A PATIENT CONTACT 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 RECEIVED AN AIR DETECTED IN CASSETTE ALARM, AN M84 PUMP ERROR ALARM, AND A MAKE SURE THE HEATHER BAG (HB) IS ON THE HEATER TRAY (HT) MESSAGE DURING FILL 6 OF 6 OF TREATMENT. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. IT WAS REPORTED THAT THE CYCLER MADE A LOUD POPPING NOISE THROUGHOUT ALL PHASES OF THE PATIENT'S TREATMENT. THE PATIENT WAS ADVISED TO DISCONTINUE THE USE OF THEIR CYCLER AND A NEW CYCLER WAS ISSUED TO THE PATIENT. THE PATIENT REVERTED TO AN ALTERNATE FORM OF TREATMENT. THE PATIENT WAS ALSO ADVISED TO FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). THERE WAS NO ADVERSE EVENT, SERIOUS INJURY, NOR MEDICAL INTERVENTION REPORTED DURING THE INITIAL CALL. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER, TO DATE A RESPONSE HAS NOT BEEN RECEIVED. THE RETURN OF THE CYCLER TO THE MANUFACTURER WAS SCHEDULED AS WELL AS THE DELIVERY OF ITS REPLACEMENT TO THE PATIENT. THE CYCLER SET USED BY THE PATIENT WAS NOT RETURNED TO THE MAN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10840316 ↗
• MalfunctionOct 31, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THE CASSETTE DOOR OF THEIR CYCLER DURING STEP 9 OF THEIR PD END TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING FILL 2 OF 5 OF 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 FLUID LEAK DID COME IN CONTACT WITH THE CYCLER. 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. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS NOT AVAILABLE. UPON FOLLOW UP, THE PDRN REPORTED THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED. THE PDRN STATED THAT TREATMENT WAS COMPLETED AFTER RECEIVING THE NEW CYCLER. THE PDRN REPORTED THAT IT IS UNKNOWN WHERE EXACTLY THE FLUID LEAK OCCURRED FROM. 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 DIAL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10767265 ↗
• MalfunctionMay 26, 2020Fluid/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 DURING FILL 1 OF THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DRAIN 0 OF 6 OF TREATMENT 10 TIMES AND THE PATIENT REPORTED THAT THEY RECEIVED A M83 PUMP A VS. B VOLUME ALARM DURING FILL 1. THE CYCLER WAS REBOOTED AND TREATMENT WAS CANCELLED. THE PATIENT REPORTED THAT THEY BYPASSED FROM DRAIN 0 TO FILL 1. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. 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. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE PATIENT STATED THAT THEY ARE TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED, AND CONFIRMED THAT THEY WERE ABLE 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 I

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10088292 ↗
• MalfunctionMar 4, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS TECHNICAL SUPPORT TO REPORT THE LIBERTY PDX CYCLER ALARMED WITH A DL DRAIN LINE IS BLOCKED MESSAGE AND BALLOON VALVE LEAK WARNING DURING STEP 2 OF SETUP. THE CYCLER ALSO PRODUCED A NOISE LIKE A MOTOR RUNNING DURING SETUP. THE FRESENIUS TECHNICAL SUPPORT REPRESENTATIVE ISSUED A REPLACEMENT CYCLER AND ADVISED THE PATIENT TO DISCONTINUE USING THE MACHINE. THE PATIENT WAS ADVISED TO INFORM THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) OF THE CYCLER REPLACEMENT. UPON FOLLOW UP WITH THE PATIENT, IT WAS CONFIRMED THAT NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS ABLE TO COMPLETE TREATMENT VIA MANUAL EXCHANGES. THE CYCLER WAS RETURNED TO THE MANUFACTURER AND A REPLACEMENT CYCLER WAS PROVIDED AND RECEIVED. UPON PHYSICAL EVALUATION OF THE CYCLER BY THE MANUFACTURER, IT WAS IDENTIFIED THAT THE TRANSFORMER ON THE INVERTER BOARD HAD AN INTERNAL SHORT.

  Patient problems: No Patient Involvement

  MAUDE report 9787546 ↗
• DeathDec 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) FOR A PATIENT ON PD THERAPY REPORTED THAT THE PATIENT EXPIRED DURING TREATMENT. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PDRN. THE PATIENT WAS IN TREATMENT WHEN THEY EXPIRED IN THEIR SLEEP. THE PATIENT WAS ALREADY DECEASED WHEN THEY WERE FOUND. NO RESUSCITATIVE EFFORTS WERE PERFORMED, AND THE PATIENT WAS NOT TRANSPORTED TO THE HOSPITAL. THE CAUSE OF DEATH IS SUSPECTED TO BE CARDIAC IN NATURE. THE PATIENT HAD A RECENT HISTORY OF MULTIPLE MYOCARDIAL INFARCTIONS UNRELATED TO USE OF ANY FRESENIUS PRODUCTS. THERE WERE NO REPORTED ISSUES WITH THE LIBERTY PDX CYCLER PRIOR TO THE DEATH.

  Patient problems: Death

  MAUDE report 9526853 ↗
• MalfunctionNov 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED FLUID LEAKING FROM THE INSIDE OF THE CASSETTE DOOR OF THEIR CYCLER AFTER THEIR PD TREATMENT WAS COMPLETED. NO MACHINE ALARMS OCCURRED PRIOR TO THE LEAK. THE CAUSE OF THE LEAK WAS UNKNOWN. THE PATIENT WAS ADVISED TO DISCONTINUE USE OF THEIR CYCLER AND FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). A NEW CYCLER WAS ISSUED TO THE PATIENT. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE PDRN STATED THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, EXPERIENCE ANY ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS TREATED WITH ONE DOSE OF PROPHYLACTIC ANTIBIOTICS, 2G CEFTAZIDIME AND 1.5G VANCOMYCIN VIA INTRAPERITONEAL ADMINISTRATION. THE PATIENT HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE CASSETTE USED BY THE PATIENT WAS RETAINED AND AVAILABLE TO BE RETURNED FOR PHYSICAL EVALUATION BY THE MANUFACTURER. THE CYCLER WAS ALSO AVAILABLE TO BE RETURNED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9335037 ↗
• MalfunctionNov 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THEIR CASSETTE LEAKED DURING AN UNKNOWN PHASE OF PD TREATMENT. UPON FOLLOW UP, THE PD REGISTERED NURSE (PDRN) CONFIRMED THE REPORTED EVENT. THE PDRN REPORTED THAT TREATMENT WAS COMPLETED WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS TREATED WITH ONE DOSE OF PROPHYLACTIC ANTIBIOTICS 2G CEFTAZIDIME AND 1.5G VANCOMYCIN VIA INTRAPERITONEAL ADMINISTRATION. THE CASSETTE USED BY THE PATIENT IS AVAILABLE. A SAMPLE RETURN KIT WAS SHIPPED TO THE CUSTOMER SO THEY CAN RETURN THE REPORTED CASSETTE TO THE MANUFACTURER. THE REPORTED CYCLER WAS REPLACED AFTER THE SECOND OCCURRENCE AND PATIENT HAS BEEN ABLE TO COMPLETE TREATMENT WITHOUT ANY ISSUES. THAT CYCLER HAS BEEN RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9334990 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT WAS HOSPITALIZED FOR ABDOMINAL PAIN AND CONSTIPATION (UNSPECIFIED DATES OF ADMISSION AND DISCHARGE). THE PATIENT INITIALLY REPORTED THE HOSPITALIZATION AFTER CALLING TO SEEK ASSISTANCE WITH THE CYCLER DRAINING SLOWLY AND RECEIVING A COMPLICATION ENCOUNTERED ALARM DURING DRAIN 4 OF 4. THE PATIENT HAD MENTIONED NOT HAVING THESE ISSUES WHILE USING THE HOSPITAL¿S CYCLER DURING A PREVIOUS HOSPITALIZATION. UPON FOLLOW UP WITH THE PD REGISTERED NURSE (PDRN) IT WAS CLARIFIED THAT THE PATIENT WAS ADMITTED ON AN UNKNOWN DATE DUE TO MORE THAN FIVE DAYS OF ABDOMINAL PAIN AND CONSTIPATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, TO DATE A RESPONSE HAS NOT BEEN RECEIVED. THERE WAS NO ALLEGATION THAT THE PATIENT¿S SYMPTOMS AND SUBSEQUENT HOSPITALIZATION WERE RELATED TO THE USE OF A FRESENIUS DEVICE, DRUG, OR PRODUCT. AS THE EVENT DATE IS UNKNOWN IT WILL BE CAPTURED AS (B)(6) 2019.

  Patient problems: Abdominal Pain; Constipation

  MAUDE report 9334085 ↗
• InjuryNov 2, 2019Adverse 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 AND OUT OF PRECAUTION THEY REQUESTED A REPLACEMENT CYCLER. HOWEVER, THERE WERE NO REPORTED ALLEGATIONS OF A LIBERTY PDX CYCLER/LIBERTY PD X CYCLER SET MALFUNCTION OR DEFICIENCY ASSOCIATED WITH THE PERITONITIS 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. A REPLACEMENT CYCLER WAS ISSUED TO THE PATIENT. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE PD REGISTERED NURSE (PDRN) STATED THAT ON (B)(6) 2019 THE PATIENT WAS EXPERIENCING ABDOMINAL PAIN AND CLOUDY EFFLUENT. AS A RESULT, THE PATIENT WENT TO THE OUTPATIENT PD CLINIC AND A PD EFFLUENT CULTURE WAS OBTAINED. THE CELL CULTURE YIELDED GROWTH OF THE BACTERIA STREPTOCOCCUS GORDONII. THE PATIENT WAS TREATED WITH GENTAMYCIN 1500 MG AND VANCOMYCIN 1.5 GRAMS INTRA-PERITONEAL (IP) ON AN OUTPATIENT BASIS. PER THE PDRN, THE PATIENT IS RECOVERING FROM THE EVENT. THERE WAS NO IDENTIFIED CAUSE FOR THE EVENT. THE NURSE INDICATED THEY DO NOT BELIEVE THE PERITONITIS WAS CAUSED BY THE USE OF A FRESENIUS DEVICE,

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 9270520 ↗
• InjuryJul 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS (PD) PATIENT'S CONTACT REPORTED THAT THE PATIENT WAS DIAGNOSES WITH PERITONITIS. UPON FOLLOW UP WITH THE PATIENT'S PD REGISTERED NURSE (PDRN) IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC ON (B)(6) 2019 WITH CLOUDY PD EFFLUENT. THE PATIENT WAS INITIATED ON ANTIBIOTIC THERAPY WITH INTRAPERITONEAL (IP) VANCOMYCIN AND CEFTAZIDIME (DOSE, FREQUENCY AND DURATION UNKNOWN). THE PD EFFLUENT CULTURE WAS OBTAINED AND WAS POSITIVE FOR GRAM POSITIVE BACTERIA (GENUS AND SPECIES REQUESTED BUT NOT PROVIDED) WITH A WHITE CELL COUNT OF 606 (UNKNOWN UNITS). AFTER THE CULTURE RESULTS WERE OBTAINED, THE CEFTAZIDIME PRESCRIPTION WAS REMOVED AND THE PATIENT ONLY REMAINED ON IP VANCOMYCIN WITH THE LAST DOSE EXPECTED (B)(6) 2019. THE CAUSE OF THE PERITONITIS IS UNKNOWN, BUT THE PDRN STATED THERE WERE NO ISSUES WITH THE LIBERTY PDX CYCLER OR LIBERTY PDX INTEGRATED SET. THE PATIENT DID NOT REQUIRE HOSPITALIZATION FOR THE PERITONITIS EVENT. THE PATIENT CONTINUED WITH PD TREATMENT ON THE CYCLER WITHOUT ANY ISSUES DURING THEIR RECOVERY. NO SAMPLES WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Peritonitis

  MAUDE report 8831761 ↗
• MalfunctionJul 3, 2019Fluid/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 DURING FILL 5 OF THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING A VOLUME ERROR ALARM PRIOR TO THE LEAK AND THE TREATMENT WAS CANCELLED. THE CAUSE OF THE LEAK IS UNKNOWN. 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. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE PATIENT¿S PDRN STATED THAT THE PATIENT IS NOT TRAINED ON PERFORMING STAT DRAINS OR MANUAL PERITONEAL DIALYSIS THERAPY AS THE PATIENT IS UNABLE TO DO CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) AND RELIES ON THE PATIENT¿S SON TO COMPLETE TREATMENT. THE PDRN CONFIRMED THAT THE PATIENT HAS RECEIVED THE REPLACEMENT CYCLER AND CONTINUING WITH PERITONEAL DIALYSIS ON THE NEW CYCLER WITHOUT ISSUE AND WITHOUT REOCCURRENCE OF THE REPORTED EVENT. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. FURTHER FOLLOW UP WITH THE PATIENT CONFIRMED THAT THE CASSETTE USED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8757606 ↗
• MalfunctionMay 10, 2019Fluid/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 DURING THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING A PUMP A VS PUMP B VOLUME ERROR ALARM DURING FILL NUMBER 2 OF 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 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. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE PDRN STATED THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED, AND CONFIRMED THAT THE PATIENT WAS ABLE 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 CASS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8599403 ↗
• DeathFeb 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS (PD) NURSE (PDRN) CONTACTED FRESENIUS MEDICAL INFORMATION TO REPORT THAT A PATIENT MAY HAVE PASSED AWAY ON THE CYCLER. THEY WERE NOT FOUND UNTIL FIVE DAYS AFTER THEY DIED. PENDING INVESTIGATION WITH THE POLICE. UPON FOLLOW UP, THE PDRN STATED THAT THERE WAS NO FURTHER INFORMATION AVAILABLE REGARDING THE PATIENT¿S DEATH. THE PDRN REPORTED THE FAMILY IS NOT FORTHCOMING WITH ANY INFORMATION AND THAT WHILE AN AUTOPSY WAS PERFORMED. THE CLINIC HAS NOT HAD ANY SUCCESS WITH OBTAINING THE DEATH CERTIFICATE DESPITE ATTEMPTING TO CONTACT THE CORONER. THE PATIENT HAS A PAST MEDICAL HISTORY OF HYPERTENSION. THE PDRN STATED IT IS UNKNOWN IF THE PATIENT DIED DURING A PD TREATMENT. THE PDRN DOES NOT HAVE ANY PD TREATMENT INFORMATION AVAILABLE. THE PDRN STATED THAT THEY WERE NOT AWARE OF ANY PDX CYCLER ISSUES AND DOES NOT SUSPECT DELFLEX OR CYCLER WAS RELATED TO THE DEATH.

  Patient problems: Death

  MAUDE report 8338996 ↗
• MalfunctionOct 25, 2018Fluid/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. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. THE PATIENT WAS ADVISED TO DISCONTINUE THE USE OF THEIR CYCLER. UPON FOLLOW UP, THE PERITONEAL DIALYSIS NURSE (PDRN) STATED THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED, AND CONFIRMED THAT THE PATIENT WAS ABLE TO COMPLETE THE PERITONEAL DIALYSIS TREATMENT BEFORE DISCOVERING THE LEAK. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8004583 ↗
• InjuryJun 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS A REPORT OF A PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS (CCPD) FOR RENAL REPLACEMENT THERAPY (RRT) WHO WAS HOSPITALIZED. DURING FOLLOW-UP, THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED THE CAUSE OF THE HOSPITALIZATION WAS UNKNOWN, AND THE PATIENT¿S DISCHARGE SUMMARY WAS UNAVAILABLE. THE PDRN STATED THAT THE PATIENT WAS DISCHARGED BUT DID NOT KNOW WHEN. ADDITIONAL INFORMATION WAS REQUESTED BUT UNAVAILABLE.

  Patient problems: No Information

  MAUDE report 7637166 ↗
• InjuryJun 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING ROUTINE FOLLOW UP ON A CUSTOMER EXPERIENCE, THE PATIENT¿S PERITONEAL DIALYSIS NURSE REPORTED THAT THE PATIENT WAS RECOVERING FROM MULTIPLE HERNIA REPAIRS. THE PATIENT WAS TREATED AT AN OUTPATIENT CLINIC. THE HERNIAS REPORTEDLY DEVELOPED AFTER THE PATIENT STARTED PERITONEAL DIALYSIS TREATMENTS. PATIENT¿S PERITONEAL DIALYSIS TREATMENTS HAVE BEEN ADJUSTED TO COMPENSATE FOR THE HERNIA REPAIR. ADDITIONAL INFORMATION WAS SOLICITED.

  Patient problems: Hernia

  MAUDE report 7564113 ↗
• MalfunctionJan 22, 2018Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS PATIENT'S CONTACT REPORTED A SUPPLY BAG ALARM DURING DWELL 2 OF 5. THE ALARM COULD NOT BE CLEARED AND THE TREATMENT WAS DISCONTINUED. WHEN REMOVING THE SET THE PATIENT FOUND FLUID LEAKING. THE SOURCE OF THE LEAK COULD NOT BE IDENTIFIED. THE CYCLER WAS REPLACED. THE CONTACT WAS ADVISED TO CONTACT THE PATIENT'S NURSE NURSE. DURING FOLLOW UP THE PATIENT'S NURSE REPORTED THE PATIENT DID NOT HAVE AN ADVERSE EVENT ASSOCIATED WITH THE LEAK. NO ANTIBIOTICS WERE PRESCRIBED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7210562 ↗