Liberty® PDx 050-87222Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00840861101993), received between Nov 20, 2017 and Jun 15, 2022 — classified as 9 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THE SECOND STAY SAFE CONNECTOR DURING STEP 8 OF THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING FILL 1 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. FLUID WAS NOT DISCOVERED IN THE PUMP MODULE AREA AND ON THE EXTERNAL OF THE CASSETTE. THE PATIENT WAS ADVISED TO DISCONTINUE THE USE OF THEIR CYCLER AND FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER; TO DATE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14691698 ↗
• 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 13021730 ↗
• 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 10840317 ↗
• 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 10767273 ↗
• InjuryOct 30, 2020Adverse 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 WAS ON HEMODIALYSIS (HD) UNTIL RECENTLY. DURING FOLLOW-UP, THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED THE PATIENT¿S LAST PERITONITIS EVENT OCCURRED ON (B)(6) 2020. THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH ABDOMINAL PAIN AND CLOUDY EFFLUENT FLUID. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT WAS OBTAINED, AND THE CELL COUNT REVEALED AN ELEVATED WHITE BLOOD CELL COUNT (RESULT NOT PROVIDED). THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND WAS ADMITTED FOR TREATMENT. THE PATIENT WAS STARTED ON INTRAPERITONEAL (IP) VANCOMYCIN (DOSAGE NOT PROVIDED) AND CEFTAZIDIME 2000 MG DAILY (DURATION NOT PROVIDED. THE PDRN STATED THE PERITONEAL EFFLUENT FLUID CULTURE RETURNED POSITIVE FOR ESCHERICHIA COLI, AND THE PATIENT CONTINUED RECEIVING THE CEFTAZIDIME (VANCOMYCIN DISCONTINUED). CAUSALITY WAS ATTRIBUTED TO POOR HAND HYGIENE FOLLOWING THE PATIENT¿S USE OF THE RESTROOM DURING THERAPY. DUE TO THE SEVERITY OF THE INFECTION, THE PATIENT¿S PD CATHETER (NOT A FRESENIUS PRODUCT) REQUIRED REMOVAL, A HEMODIALYSIS CATHETER (NOT A FRESENIUS PRODUCT) WAS SURGICALLY PLACED, AND THE PATIENT WAS TRANSI

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 10763220 ↗
• InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS (PD) PATIENT REPORTED TO FRESENIUS THAT THEY EXPERIENCED A CATHETER INFECTION. THERE WAS NO ALLEGATION THAT THE EVENT WAS DUE TO THE DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT OR DEVICE. CLARIFICATION OF THE EVENT DETAILS WERE PROVIDED VIA FOLLOW-UP WITH THE PATIENT'S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). THE PDRN STATED THIS PATIENT PRESENTED TO THE OUTPATIENT CLINIC WITH CLOUDY PERITONEAL EFFLUENT FLUID. PERITONEAL EFFLUENT FLUID CULTURES TAKEN IN THE OUTPATIENT CLINIC PRESENTED WITH STAPHYLOCOCCUS CAPITIS AND A WHITE BLOOD CELL COUNT (WBC) OF 4/MM3. THE PATIENT WAS DIAGNOSED WITH PERITONITIS DUE TO TOUCH CONTAMINATION DURING CONTINUOUS CYCLIC PD (CCPD) THERAPY ON THE LIBERTY PDX CYCLER AT HOME. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND PRESCRIBED INTRAPERITONEAL VANCOMYCIN AT 2000 MG EVERY FIVE DAYS FOR THREE WEEKS. IT WAS CONFIRMED THE PATIENT¿S DIAGNOSIS OF PERITONITIS WAS NOT DUE TO A FRESENIUS DEVICE DEFICIENCY OR MALFUNCTION. THE PATIENT HAS RECOVERED FROM THE EVENT AND WAS CONTINUING CCPD THERAPY ON THE SAME LIBERTY PDX CYCLER AT HOME.

  Patient problems: Peritonitis

  MAUDE report 10696459 ↗
• MalfunctionJul 8, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THE PATIENT LINE DURING DWELL 1 OF 5 OF THEIR PD TREATMENT. THE CAUSE OF THE LEAK WAS DUE TO A HOLE IN THE TUBING. THE PATIENT WAS ADVISED TO RESET UP WITH NEW SUPPLIES AND FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). UPON FOLLOW UP, 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 PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED, AND STATED THE PATIENT COMPLETED TREATMENT ON THE CYCLER. THE PATIENT IS CONTINUING WITH PERITONEAL DIALYSIS ON THEIR CYCLER WITHOUT ISSUE AND WITHOUT REOCCURRENCE OF THE REPORTED EVENT. THE CASSETTE WAS DISCARDED AND NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10244108 ↗
• InjuryJun 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS (CCPD) FOR RENAL REPLACEMENT THERAPY (RRT) WAS HOSPITALIZED FOR PERITONITIS. DURING FOLLOW-UP, THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) REPORTED THE PATIENT WAS HOSPITALIZED ON (B)(6) 2020 FOR SUSPECTED COVID-19 INFECTION, FEVER, AND GENERALIZED WEAKNESS. THE PATIENT WAS TESTED FOR COVID-19 AND THE RESULTS WERE NEGATIVE. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT WAS OBTAINED, AND THE CELL COUNT REVEALED AN ELEVATED WHITE BLOOD CELL (WBC) COUNT (VALUE NOT PROVIDED). THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) VANCOMYCIN 1000 MG (FREQUENCY, DURATION NOT PROVIDED). THE CULTURE RETURNED POSITIVE FOR PSEUDOMONAS AERUGINOSA ON (B)(6) 2020, AND THE VANCOMYCIN WAS CONTINUED. THE PATIENT CONTINUED UNDERGOING CCPD WHILE HOSPITALIZED, AND WAS TRANSFERRED TO A REHABILITATION HOSPITAL FOR DECONDITIONING, STRENGTH TRAINING AND PHYSICAL THERAPY ON (B)(6) 2020. THE PATIENT CONTINUED TO UNDERGO CCPD WHILE ADMITTED TO THE REHABILITATION HOSPITAL AND WAS DISCHARGED ON (B)(6) 2020 IN STABLE CONDITION. THE PDRN ATTRIBUTES CAUSALITY OF PERITONITIS TO TOUCH CONTAMINATION DUE TO POOR ASEPTIC TECHNIQUE. PER

  Patient problems: Fever; Peritonitis; Weakness

  MAUDE report 10167912 ↗
• MalfunctionMay 27, 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 10093139 ↗
• InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS NURSE (PDRN) FOR A PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) FOR RENAL REPLACEMENT THERAPY (RRT) CONTACTED TECHNICAL SUPPORT TO ORDER SUPPLIES AND DURING THE CALL THE PDRN REPORTED THE PATIENT HAS PERITONITIS. THE CASSETTE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURE FOR EVALUATION. UPON FOLLOW UP, THE PDRN STATED THE PATIENT PRESENTED ABDOMINAL PAIN, GENERALLY NOT FEELING WELL, AND A CLOUDY PD EFFLUENT. A PD EFFLUENT CULTURE WAS OBTAINED, AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PATIENT¿S PERITONITIS WAS TOUCH CONTAMINATION. THE PDRN REPORTED THAT THE PATIENT STATED THAT THEY HAD BECOME LAZY WITH TREATMENT SET-UP AND DID NOT FOLLOW PROPER ASEPTIC TECHNIQUE. THE PATIENT¿S CULTURE RESULTS WERE POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS. THE DATE OF THE CULTURE WAS NOT PROVIDED. THE PATIENT WAS INITIALLY PRESCRIBED AND TREATED WITH INTRAPERITONEAL (IP) ANTIBIOTICS CEFTAZIDIME 2 GRAMS AND VANCOMYCIN 2,000 MILLIGRAMS. THE FREQUENCY AND DURATION FOR BOTH ANTIBIOTICS WERE NOT PROVIDED. THE 2 GRAMS OF CEFTAZIDIME WAS DISCONTINUED, AND THE VANCOMYCIN DOSE WAS INCREASED TO 2,200MG WITH THE LAST DOSE SCH

  Patient problems: Abdominal Pain; Malaise; Peritonitis

  MAUDE report 10056952 ↗
• InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) FOR RENAL REPLACEMENT THERAPY (RRT) EXPERIENCED PERITONITIS. UPON FOLLOW-UP WITH THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE [(PD)RN], IT WAS REPORTED THE PATIENT PRESENTED TO THE OUTPATIENT HOME DIALYSIS CLINIC WITH COMPLAINTS OF LOWER ABDOMINAL PAIN AND CLOUDY EFFLUENT ON (B)(6) 2020. THE PDRN REPORTED PERITONEAL EFFLUENT FLUID CULTURES TAKEN ON (B)(6) 2020, WERE POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS AND A CELL COUNT REVEALED INCREASED WHITE BLOOD CELLS (VALUE NOT PROVIDED). THE PDRN REPORTED THE PATIENT WAS DIAGNOSED WITH PERITONITIS, DUE TO TOUCH CONTAMINATION DURING CONTINUOUS CYCLIC PD (CCPD) THERAPY UTILIZING THE LIBERTY PDX CYCLER AT HOME. THE PATIENT WAS PRESCRIBED INTRAPERITONEAL VANCOMYCIN 1500 MG, EVERY FOUR DAYS FOR THREE TREATMENTS. THE PATIENT IS RECOVERING FROM THE EVENTS AND CONTINUES TO UNDERGO CCPD THERAPY ON THE SAME LIBERTY PDX CYCLER WITHOUT FURTHER INCIDENT OR ADVERSE EVENT.

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 9944290 ↗
• InjuryJan 15, 2020Adverse 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 HAD ORDERED MANUAL DRAIN BAGS AND MANUAL SOLUTIONS. DURING FOLLOW-UP, THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) REPORTED THE PATIENT PRESENTED TO THE OUTPATIENT HOME DIALYSIS CLINIC ON (B)(6) 2019 (DISCHARGE DATE NOT PROVIDED) WITH ABDOMINAL PAIN. A PERITONEAL EFFLUENT FLUID CULTURE WAS OBTAINED AND WAS NEGATIVE FOR GROWTH; HOWEVER, A CELL COUNT REVEALED AN ELEVATED WHITE BLOOD CELL (WBC) COUNT OF 1203 U/L. THE PATIENT WAS TREATED AS AN OUTPATIENT WITH INTRAPERITONEAL (IP) VANCOMYCIN 1-GRAM DAILY FOR 21 DAYS AND HAS RECOVERED FROM THE EVENTS. PER THE PDRN, THE EVENTS WERE UNRELATED TO THE UTILIZATION OF THE LIBERTY PDX CYCLER, LIBERTY PDX INTEGRATED SET OR ANY FRESENIUS PRODUCT(S) OR DEVICE(S). THE CAUSE OF THE PERITONITIS WAS ATTRIBUTED TO TOUCH CONTAMINATION, WHEN THE PATIENT TOUCHED THE PD CATHETER (NOT A FRESENIUS PRODUCT) WITHOUT DONNING GLOVES. THE PATIENT CONTINUES TO UNDERGO CCPD THERAPY UTILIZING THE SAME LIBERTY PDX CYCLER AS BEFORE THE EVENTS WITHOUT ISSUE. BASED ON THE INFORMATION AVAILABLE, THE LIBERTY PDX CYCLER AND LIBERTY PDX INTEGRATED SET CAN BE DISASSOCIATED FROM THE EVENT

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 9591417 ↗
• MalfunctionNov 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THE STAY SAFE CONNECTION DURING PD TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DRAIN 0 OF 4 OF TREATMENT AND A FLUID LEAK WAS DISCOVERED DURING FILL 1 OF 4. 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 CASSETTE USED BY THE PATIENT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9338963 ↗
• 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 9335065 ↗
• 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 9335026 ↗
• 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 9270523 ↗
• InjuryOct 24, 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 HAS PERITONITIS. UPON FOLLOW UP WITH THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN), THE PATIENT HAD SUSPECTED PERITONITIS ON THE DATE OF THE CALL TO CUSTOMER SUPPORT DUE TO CLOUDY EFFLUENT AND ABDOMINAL PAIN. ON 16/OCT/2019 THE PATIENT WAS SEEN IN THE PD CLINIC AND DIAGNOSED WITH PERITONITIS. A PD EFFLUENT CULTURE WAS OBTAINED, AND THE PATIENT RECEIVED A LOADING DOSE OF INTRAPERITONEAL (IP) ANTIBIOTICS. THE PATIENT WAS ADMINISTERED IP VANCOMYCIN 1750ML AND IP CEFTAZIDIME 2G. THE PD EFFLUENT CULTURE RESULTED POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS WITH A WHITE CELL COUNT OF 377 (UNKNOWN UNITS) WITH 58% POLYMORPHONUCLEAR CELLS. THE CEFTAZIDIME WAS DISCONTINUED, AND THE PATIENT REMAINED ON THE IP VANCOMYCIN (DOSE, FREQUENCY AND DURATION UNKNOWN). THE PATIENT DID NOT REQUIRE HOSPITALIZATION FOR THE EVENT. THE CAUSE OF THE PERITONITIS HAS BEEN ATTRIBUTED TO TOUCH CONTAMINATION BY THE PATIENT. THERE WERE NO ISSUES WITH THE LIBERTY PDX CYCLER OR PDX INTEGRATED SET. THE PATIENT CONTINUES PD THERAPY WITH THE CYCLER DURING RECOVERY.

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 9234408 ↗
• 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 (B)(6) FOR GRAM (B)(6) 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 8831758 ↗
• 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 8757648 ↗
• 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 8599404 ↗
• MalfunctionDec 21, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THE PATIENT LINE. THE PATIENT STATED THAT THEY WOKE UP AND THEIR PATIENT LINE WAS DISCONNECTED. 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 CANCEL TREATMENT AND INFORM THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). UPON FOLLOW UP, THE PERITONEAL DIALYSIS NURSE (PDRN) STATED THE PATIENT HAD NOT REPORTED THE LEAK TO THEM. THERE WAS NO KNOWN ADVERSE EVENTS OR MEDICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8190355 ↗
• 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 8004574 ↗
• MalfunctionJul 24, 2018Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY PERITONEAL DIALYSIS NURSE (PDRN) REPORTED THAT THERE WAS A SPLIT IN THE LINE OF A PATIENT'S CASSETTE CAUSING LIQUID TO LEAK ALL OVER THE PATIENT'S FLOOR DURING THEIR PERITONEAL DIALYSIS (PD) TREATMENT. UPON FOLLOW UP, THE PDRN REPORTED THAT DURING THE PATIENT¿S FIRST DWELL, A PUDDLE OF WATER WAS ON THE FLOOR. THE PATIENT ASSESSED THE TUBING AND FOUND THAT THE PATIENT LINE FROM THE CASSETTE HAD A LEAK. THE LEAK APPEARED AS A CLEAN CUT IN THE TUBING. PER THE PDRN, THE PATIENT STATED THAT NO SCISSORS OR KNIVES WERE USED NEAR ANY OF THE CASSETTES WHEN OPENING THE BOX OR PACKAGE. THE PATIENT CALLED THE ON-CALL NURSE AND THE NURSE GAVE THEM INSTRUCTIONS TO DISCONNECT FROM TREATMENT AND TO CALL THEIR CLINIC FIRST THING IN THE MORNING. THERE WERE NO CHANGES IN THE PATIENT¿S STATUS AS IT RELATES TO THE REPORTED EVENT. THE PATIENT¿S PD FLUID WAS CULTURED AND (B)(6) FOR ANY INFECTION. THE PATIENT DID NOT COMPLETE TREATMENT ON THE DAY OF THE EVENT, HOWEVER RESUMED TREATMENT THE NEXT DAY. THE PATIENT IS REPORTED TO BE STABLE AND THE PRODUCT WAS SCHEDULED TO BE PICKED UP FROM THE PATIENT¿S HOME ON THE NEXT SUPPLY DELIVERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7714559 ↗
• MalfunctionMay 9, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A FLUID LEAK WAS IDENTIFIED COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE PATIENT STATED THAT DURING THE FIRST FILL THE CASSETTE LEAKED FLUID FROM THE PIN. THE PATIENT CONFIRMED THAT NO FLUID WAS ON THE CYCLER. THE PATIENT WAS ADVISED TO CANCEL TREATMENT AND SETUP WITH NEW SUPPLIES TO COMPLETE TREATMENT. DURING FOLLOW UP, THE PDRN CONFIRMED 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 CONTINUE PD THERAPY WITH NO FURTHER ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7497912 ↗
• MalfunctionMar 13, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS PATIENT IDENTIFIED A FLUID LEAK COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. PRIOR TO THE EVENT, THE PATIENT RECEIVED A DRAIN COMPLICATIONS ALARM DURING DRAIN TWO OF THEIR THERAPY. FOLLOWING THE ALARM, THE PATIENT CONTACTED A TECHNICAL SUPPORT REPRESENTATIVE FOR ASSISTANCE. DURING TROUBLESHOOTING, IT WAS VERIFIED THAT THE CONNECTIONS WERE TIGHT AND THE CLAMPS WERE OPEN. DURING THE CALL THE PATIENT NOTED THAT LAST NIGHT THEY WERE UNABLE TO COMPLETE TREATMENT DUE TO HAVING A FLUID LEAK FROM THE STAY SAFE CONNECTOR. THE CAUSE OF THE LEAK WAS UNKNOWN. THE TECHNICAL SUPPORT REPRESENTATIVE ADVISED THE PATIENT TO DISCONTINUE USE OF THE CYCLER AND TO NOTIFY THEIR PERITONEAL DIALYSIS REGISTERED NURSE OF THE EVENT. THE PATIENT REVERTED TO MANUAL SUPPLIES TO COMPLETE THEIR TREATMENT. FOLLOW UP WITH THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE VERIFIED THAT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED LEAK. PER THE CLINIC¿S PROCEDURE THE PATIENT WAS PRESCRIBED PROPHYLACTIC INTRAPERITONEAL (IP) ANTIBIOTIC VANCOMYCIN 1G, ONE DOSAGE FOLLOWING THE EVENT. THE CAUSE FOR THE LEAK WAS NOTED TO BE THE PATENT NO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7335570 ↗