Liberty® 050-87215Recalls & reported problems

Summary

The FDA's MAUDE database contains 279 adverse event reports that list this exact device (DI 00840861100743), received between May 31, 2017 and Apr 2, 2025 — classified as 1 death, 103 injuries, 175 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (177 reports).

10 other recalls cover devices cleared under the same FDA submission (K043363, 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 279 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE PATIENT¿S PERITONEAL DIALYSIS NURSE (PDRN) 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. A BALLOON VALVE LEAK ALARM OCCURRED DURING FILL 1 OF 1 OF TREATMENT AND THE TREATMENT WAS CANCELLED. THE CYCLER WAS RESET UP WITH NEW SUPPLIES. 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. A NEW CYCLER WAS ISSUED TO THE PATIENT. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE PDRN NOTED THAT THE LOCATION OF THE LEAK WAS DIRECTLY FROM THE CASSETTE, DROPPING OUT THE BOTTOM OF THE DOOR ONTO THE FLOOR BELOW THE CYCLER. ALL CONNECTED CORRECTLY AS THE PDRN SET UP THE CYCLER. THE PATIENT WAS NOT ABLE TO USE THE CYCLER OVERNIGHT FOR DIALYSIS, IT WAS SUPPOSED TO BE THE FIRST TREATMENT AT HOME FOR HIM AND HE WAS VERY CONCERNED THAT A BRAND NEW MACHINE WAS BROKEN ON ARRIVAL. THE PATIENT HAD TO DO MANUAL EXCHANGES, BUT THE PATIENT IS STILL IN TRAINING, IT WAS THE VERY FIRST TIME AT HOME USING THE CYCLER AND NOW TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752416 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED A PATIENT ON PERITONEAL DIALYSIS (PD) WAS HOSPITALIZED WITH PERITONITIS. THERE WERE NO REPORTED ALLEGATIONS THAT THE EVENT WAS RELATED TO ANY ISSUES WITH FRESENIUS PRODUCTS. THE EVENT WAS REPORTED WHEN PLACING THE PATIENT ON HOLD FOR PD THERAPY AS THE PATIENT IS EXPECTED TO HAVE THE PD CATHETER (NOT A FRESENIUS PRODUCT) REMOVED AND TRANSITION TO HEMODIALYSIS. IN ADDITIONAL FOLLOW-UP, THE PATIENT¿S PD NURSE STATED THE PATIENT WAS HAVING SYMPTOMS OF ABDOMINAL PAIN. ON (B)(6) 2024, THE PATIENT WAS SEEN IN THE OUTPATIENT PD CLINIC AND HAD A PD CULTURE OBTAINED. PER THE NURSE, THE PD CULTURE GREW ESCHERICHIA COLI AND KLEBSIELLA. THE PATIENT WAS INITIATED ON MEROPENEM 1 GRAM AND VANCOMYCIN 1 GRAM INTRA-PERITONEAL (IP) ON AN OUTPATIENT BASIS. HOWEVER, SUBSEQUENTLY ON (B)(6) 2024, THE PATIENT WAS ADMITTED INTO THE HOSPITAL FOR PERSISTENT SYMPTOMS OF ABDOMINAL DESPITE ANTIBIOTIC THERAPY. THE NURSE CONFIRMED THAT THE PATIENT IS EXPECTED TO HAVE THE PD CATHETER REMOVED WITH TRANSITION TO HEMODIALYSIS FOR RENAL REPLACEMENT NEEDS. THE PATIENT REMAINED IN THE HOSPITAL AT THE TIME FOLLOW-UP WAS PERFORMED AND IS EXPECTED TO UNDERGO PD CATHETER REPAIR. NO FURTHER INFORMATION ABOUT

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 20561290 ↗
• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 10/JUL/2024, A PATIENT CONTACT REPORTED TO FRESENIUS CUSTOMER SERVICE THIS PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLIC PD (CCPD) THERAPY UTILIZING THE LIBERTY SELECT CYCLER EXPERIENCED AN INFECTION AND WAS HOSPITALIZED. THERE WAS NO SPECIFIC ALLEGATION THIS ADVERSE EVENT WAS RELATED TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S) IN THE INITIAL REPORTING. UPON FOLLOW UP WITH THE PATIENT¿S PD REGISTERED NURSE, IT WAS REPORTED THIS PATIENT WAS HOSPITALIZED ON (B)(6) 2024 FOLLOWING ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID. PERITONEAL EFFLUENT FLUID CULTURES AND A WHITE BLOOD CELL (WBC) COUNT TAKEN IN THE HOSPITAL ON 29/JUN/2024 PRESENTED WITH CANDIDA PARAPSILOSIS IN THE CULTURE AND AN ELEVATED WBC COUNT (EXACT COUNT NOT REPORTED). THE PATIENT WAS DIAGNOSED WITH PERITONITIS DUE TO UNKNOWN ETIOLOGY. THE PATIENT WAS PRESCRIBED INTRAPERITONEAL VANCOMYCIN AT 2000 MG EVERY THREE DAYS FOR TWO WEEKS AND ORAL FLUCONAZOLE AT 200 MG DAILY FOR TWO WEEKS. THE PATIENT¿S PD CATHETER WAS REMOVED DUE TO THE NATURE OF THIS FUNGAL INFECTION. THE PATIENT RECEIVED A CENTRAL VASCULAR CATHETER IN FAVOR OF HEMODIALYSIS (HD) AS THE PATIENT WAS TRANSITIONED TO HD

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 19797149 ↗
• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, A PATIENT CONTACT REPORTED TO FRESENIUS CUSTOMER SERVICE THIS PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLIC PD (CCPD) THERAPY UTILIZING THE LIBERTY SELECT CYCLER EXPERIENCED AN INFECTION AND WAS HOSPITALIZED. THERE WAS NO SPECIFIC ALLEGATION THIS ADVERSE EVENT WAS RELATED TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S) IN THE INITIAL REPORTING. UPON FOLLOW UP WITH THE PATIENT¿S PD REGISTERED NURSE, IT WAS REPORTED THIS PATIENT WAS HOSPITALIZED ON (B)(6) 2024 FOLLOWING ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID. PERITONEAL EFFLUENT FLUID CULTURES AND A WHITE BLOOD CELL (WBC) COUNT TAKEN IN THE HOSPITAL ON (B)(6) 2024 PRESENTED WITH CANDIDA PARAPSILOSIS IN THE CULTURE AND AN ELEVATED WBC COUNT (EXACT COUNT NOT REPORTED). THE PATIENT WAS DIAGNOSED WITH PERITONITIS DUE TO UNKNOWN ETIOLOGY. THE PATIENT WAS PRESCRIBED INTRAPERITONEAL VANCOMYCIN AT 2000 MG EVERY THREE DAYS FOR TWO WEEKS AND ORAL FLUCONAZOLE AT 200 MG DAILY FOR TWO WEEKS. THE PATIENT¿S PD CATHETER WAS REMOVED DUE TO THE NATURE OF THIS FUNGAL INFECTION. THE PATIENT RECEIVED A CENTRAL VASCULAR CATHETER IN FAVOR OF HEMODIALYSIS (HD) AS THE PATIENT WAS TRANSITIONED TO HD

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 19794555 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, IT WAS REPORTED THAT THIS PATIENT ON PERITONEAL DIALYSIS (PD) WAS HOSPITALIZED FOR PERITONITIS. THERE WERE NO REPORTED ALLEGATIONS THAT THE EVENT WAS RELATED TO ANY ISSUES WITH FRESENIUS PRODUCTS. IN ADDITIONAL FOLLOW-UP, THE PATIENT¿S PD NURSE CONFIRMED THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024 FOR PERITONITIS. HOWEVER, THE NURSE WAS NOT ABLE TO PROVIDE ANY DETAILS ABOUT THE HOSPITALIZATION, INCLUDING PD CULTURE RESULTS AND TREATMENT INFORMATION. THE NURSE STATED THE PATIENT IS BEING TRANSITIONED TO HEMODIALYSIS FOR RENAL REPLACEMENT NEEDS. THE PATIENT REMAINED IN THE HOSPITAL AT THE TIME FOLLOW-UP WAS PERFORMED. THE PATIENT¿S NURSE WAS NOT ABLE TO IDENTIFY THE EXACT CAUSE OF THE PATIENT¿S PERITONITIS IS UNKNOWN. HOWEVER, THE NURSE CONFIRMED THE PATIENT DID NOT HAVE ANY FLUID LEAKS OR ISSUES WITH FRESENIUS PRODUCTS IN RELATION TO THIS EVENT.

  Patient problems: Peritonitis

  MAUDE report 19748158 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, IT WAS REPORTED THAT THIS PATIENT ON PERITONEAL DIALYSIS (PD) WAS HOSPITALIZED FOR PERITONITIS. THERE WERE NO REPORTED ALLEGATIONS THAT THE EVENT WAS RELATED TO ANY ISSUES WITH FRESENIUS PRODUCTS. IN ADDITIONAL FOLLOW-UP, THE PATIENT¿S PD NURSE CONFIRMED THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024 FOR PERITONITIS. HOWEVER, THE NURSE WAS NOT ABLE TO PROVIDE ANY DETAILS ABOUT THE HOSPITALIZATION, INCLUDING PD CULTURE RESULTS AND TREATMENT INFORMATION. THE NURSE STATED THE PATIENT IS BEING TRANSITIONED TO HEMODIALYSIS FOR RENAL REPLACEMENT NEEDS. THE PATIENT REMAINED IN THE HOSPITAL AT THE TIME FOLLOW-UP WAS PERFORMED. THE PATIENT¿S NURSE WAS NOT ABLE TO IDENTIFY THE EXACT CAUSE OF THE PATIENT¿S PERITONITIS IS UNKNOWN. HOWEVER, THE NURSE CONFIRMED THE PATIENT DID NOT HAVE ANY FLUID LEAKS OR ISSUES WITH FRESENIUS PRODUCTS IN RELATION TO THIS EVENT.

  Patient problems: Peritonitis

  MAUDE report 19748156 ↗
• MalfunctionJul 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT CONTACT DISCOVERED A FLUID LEAK DURING DWELL 2 OF 4 OF THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DWELL 2 OF 4 OF TREATMENT AND THE TREATMENT WAS CANCELLED. FLUID WAS SEEN UNDERNEATH THE CYCLER CART. FLUID WAS NOT DISCOVERED IN THE PUMP MODULE AREA OR ON THE EXTERNAL OF THE CASSETTE. THE CAUSE OF THE LEAK IS UNKNOWN. THE PATIENT CONTACT DOES NOT SEE ANY RIPS OR TEARS IN THE HEATER BAG (HB). UPON FOLLOW UP, THE PATIENT CONTACT CONFIRMED THE REPORTED EVENT. THE PATIENT CONTACT 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 CONTACT STATED THAT THE PATIENT WAS ABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT USING NEW SUPPLIES WITH THE CYCLER. THE PATIENT CONTACT CONFIRMED THAT THE PATIENT IS CONTINUING WITH PERITONEAL DIALYSIS ON THE CYCLER WITHOUT ISSUE AND WITHOUT REOCCURRENCE OF THE REPORTED EVENT. THE PATIENT CONTACT CONFIRMED THAT THE CYCLER SET IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19670370 ↗
• InjuryMay 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THIS PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLIC PD (CCPD) THERAPY UTILIZING THE LIBERTY SELECT CYCLER REPORTED TO FRESENIUS CUSTOMER SERVICE SHE EXPERIENCED PERITONITIS. THERE WAS NO SPECIFIC ALLEGATION THIS ADVERSE EVENT WAS RELATED TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S) IN THE INITIAL REPORTING. UPON FOLLOW UP WITH THE PATIENT¿S PD REGISTERED NURSE, IT WAS REPORTED THIS PATIENT WAS HOSPITALIZED ON (B)(6) 2024 FOLLOWING ABDOMINAL PAIN AND FEVER. PERITONEAL EFFLUENT FLUID CULTURES AND A WHITE BLOOD CELL (WBC) COUNT TAKEN IN THE HOSPITAL PRESENTED WITH ENTEROCOCCUS FAECALIS IN THE CULTURE AND AN ELEVATED WBC COUNT (EXACT NUMBER NOT REPORTED). THE PATIENT WAS DIAGNOSED WITH PERITONITIS DUE TO A BREAK IN ASEPSIS DURING CCPD THERAPY ON THE LIBERTY SELECT CYCLER AT HOME. THE PATIENT WAS PRESCRIBED INTRAPERITONEAL (IP) VANCOMYCIN AT 2000 MG EVERY 5 DAYS AND IP CEFTAZIDIME AT 1000 MG DAILY TO ADDRESS THE INFECTION. THE IP CEFTAZIDIME WAS DISCONTINUED UPON CULTURE RESULTS. THE PATIENT WAS ABLE TO UNDERGO CONTINUOUS AMBULATORY PD (CAPD) THERAPY UTILIZING MANUAL EXCHANGES DURING THIS ADMISSION AS CAPD WAS THE PREFERENCE FOR RENAL RE

  Patient problems: Abdominal Pain; Fever; Peritonitis

  MAUDE report 19405643 ↗
• MalfunctionMay 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THE PIN AREA ON THE PATIENT LINE DURING FILL 1 OF THEIR PD TREATMENT. THE PATIENT STATED THAT THERE WAS A PIECE WHERE THE PIN GOES THAT WAS NOT ALIGNED WHICH CAUSED FLUID TO SPRAY OUT OF THE PATIENT LINE ONTO THE BED. THE PATIENT WAS ADVISED TO RESET UP TREATMENT WITH NEW SUPPLIES. UPON FOLLOW UP, IT WAS CONFIRMED THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE CYCLER SET USED BY THE PATIENT WAS AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19238509 ↗
• MalfunctionApr 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) DISCOVERED A FLUID LEAK ON THE BOTTOM AREA OF THE CASSETTE DOOR OF THE CYCLER DURING DRAIN 3 OF 4 AND ALSO AT THE END OF THE PD TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM PRIOR TO THE LEAK. THE CAUSE OF THE LEAK IS UNKNOWN. FLUID WAS DISCOVERED IN THE PUMP MODULE AREA AND ON THE EXTERNAL OF THE CASSETTE. THE PDRN WAS ADVISED TO DISREGARD THE USE OF THE CYCLER UNTIL THE NEXT DAY AND FOLLOW UP WITH THE PATIENT'S ON-CALL PDRN. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE PDRN CONFIRMED THE REPORTED EVENT, AND THAT FLUID WAS FOUND UNDERNEATH THE CYCLER AS WELL. THE PDRN STATED THAT PER THE CLINIC¿S PROCEDURE THE PATIENT WAS PRESCRIBED PROPHYLACTIC ANTIBIOTICS (TYPE UNKNOWN, DOSE UNKNOWN, ORAL, THREE DAYS). THE PDRN 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 PDRN STATED THAT THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED, AND STATED THE PATIENT WAS ABL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19110900 ↗
• MalfunctionFeb 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT¿S CARETAKER REPORTED THAT DURING PD TREATMENT THERE WAS A FLUID LEAK ENCOUNTERED. THERE WAS AN AIR DETECTED IN CASSETTE WARNING DURING DWELL 5 OF 6. TREATMENT WAS STOPPED AND THERE WAS FLUID FOUND IN THE PUMP MODULE AND ON THE EXTERNAL CASSETTE. IN A FOLLOW UP, THE CAREGIVER VERIFIED THERE WERE NO SYMPTOMS, ADVERSE EVENTS, OR INJURIES REQUIRING MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE CAREGIVER IS LETTING THE CYCLER AIR DRY AND WILL RESUME USE. THE CYCLER SET IS NOT AVAILABLE TO RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18742512 ↗
• MalfunctionFeb 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT¿S CARETAKER REPORTED THAT DURING PD TREATMENT THERE WAS A FLUID LEAK ENCOUNTERED. THERE WAS AN AIR DETECTED IN CASSETTE WARNING DURING DRAIN 4 OF 6. TREATMENT WAS STOPPED AND THERE WAS FLUID FOUND IN THE PUMP MODULE AND ON THE EXTERNAL CASSETTE. IN A FOLLOW UP, THE CAREGIVER VERIFIED THERE WERE NO SYMPTOMS, ADVERSE EVENTS, OR INJURIES REQUIRING MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE CAREGIVER IS LETTING THE CYCLER AIR DRY AND WILL RESUME USE. THE CYCLER SET IS NOT AVAILABLE TO RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18731535 ↗
• MalfunctionJan 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY A PERITONEAL DIALYSIS (PD) PATIENT THAT A FLUID LEAK TOOK PLACE DURING PD TREATMENT. DURING DRAIN 2 OF 6 THE PATIENT ENCOUNTERED A DRAINING SLOWLY WARNING. THE PATIENT HAD BECOME DISCONNECTED FROM THE STAY SAFE CONNECTOR AND FLUID HAD DRAINED OUT INTO THE BED. UPON FOLLOW UP, THE PATIENT¿S PD NURSE VERIFIED THERE WERE NO SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRED MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT INDICATED THAT THE CONNECTOR SEEMED FAULTY. THE PATIENT IS USING THE SAME CYCLER AND IS ABLE TO CONTINUE PD TREATMENT WITH NO FURTHER ISSUES. THE CYCLER SET USED BY THE PATIENT IS NOT AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18592152 ↗
• MalfunctionJan 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT REPORTED HAVING A FLUID LEAK ASSOCIATED WITH PD TREATMENT. THE PATIENT ENCOUNTERED AN AIR DETECTED IN CASSETTE WARNING DWELL 1 OF 4. PATIENT CANCELLED TREATMENT AND DISCOVERED FLUID IN THE PUMP MODULE AREA AND ON THE EXTERNAL CASSETTE. IN A FOLLOW UP, THE PATIENT'S PD NURSE CONFIRMED THE REPORTED EVENT. THE NURSE SAID 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. 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 CYCLER SET WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18478051 ↗
• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 29/NOV/2023, THIS PATIENT ON PERITONEAL DIALYSIS (PD) THERAPY REPORTED SHE HAD PERITONITIS THE FIRST WEEK OF NOVEMBER. THERE WERE NO REPORTED ALLEGATIONS THAT THE PERITONITIS WAS RELATED TO ANY ISSUES WITH FRESENIUS PRODUCTS. THE PATIENT REPORTED SHE WAS NOT HOSPITALIZED AND RECEIVED ANTIBIOTIC TREATMENT. IN ADDITIONAL FOLLOW-UP, THE PATIENT¿S PD NURSE CONFIRMED THAT ON (B)(6) 2023, THE PATIENT WAS SEEN IN THE OUTPATIENT PD CLINIC FOR SYMPTOMS OF ABDOMINAL PAIN. THE PATIENT HAD A PD CULTURE OBTAINED WHICH GREW THE BACTERIA STREPTOCOCCUS MITIS. THE PATIENT WAS TREATED WITH INTRA-PERITONEAL (IP ANTIBIOTIC THERAPY WITH VANCOMYCIN (DOSE NOT PROVIDED) AND CEFTAZIDIME (DOSE NOT PROVIDED) ON AN OUTPATIENT BASIS. THE PATIENT HAS RECOVERED AND IS COMPLETING PD TREATMENT WITH THE SAME CYCLER. THE NURSE CONFIRMED THE PATIENT DID NOT HAVE ANY FLUID LEAKS OR ANY ISSUES WITH FRESENIUS PRODUCTS IN RELATION TO THE PERITONITIS EVENT. THE NURSE ATTRIBUTED THE PERITONITIS TO A BREACH IN ASEPTIC TECHNIQUE AS THE PATIENT WAS NOT WEARING A MASK DURING THE PD PROCEDURE.

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 18294945 ↗
• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THIS PATIENT ON PERITONEAL DIALYSIS (PD) THERAPY REPORTED SHE HAD PERITONITIS THE FIRST WEEK OF NOVEMBER. THERE WERE NO REPORTED ALLEGATIONS THAT THE PERITONITIS WAS RELATED TO ANY ISSUES WITH FRESENIUS PRODUCTS. THE PATIENT REPORTED SHE WAS NOT HOSPITALIZED AND RECEIVED ANTIBIOTIC TREATMENT. IN ADDITIONAL FOLLOW-UP, THE PATIENT¿S PD NURSE CONFIRMED THAT ON (B)(6) 2023, THE PATIENT WAS SEEN IN THE OUTPATIENT PD CLINIC FOR SYMPTOMS OF ABDOMINAL PAIN. THE PATIENT HAD A PD CULTURE OBTAINED WHICH GREW THE BACTERIA STREPTOCOCCUS MITIS. THE PATIENT WAS TREATED WITH INTRA-PERITONEAL (IP ANTIBIOTIC THERAPY WITH VANCOMYCIN (DOSE NOT PROVIDED) AND CEFTAZIDIME (DOSE NOT PROVIDED) ON AN OUTPATIENT BASIS. THE PATIENT HAS RECOVERED AND IS COMPLETING PD TREATMENT WITH THE SAME CYCLER. THE NURSE CONFIRMED THE PATIENT DID NOT HAVE ANY FLUID LEAKS OR ANY ISSUES WITH FRESENIUS PRODUCTS IN RELATION TO THE PERITONITIS EVENT. THE NURSE ATTRIBUTED THE PERITONITIS TO A BREACH IN ASEPTIC TECHNIQUE AS THE PATIENT WAS NOT WEARING A MASK DURING THE PD PROCEDURE.

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 18294939 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT'S CONTACT REPORTED THAT THIS PATIENT ON PD THERAPY HAS PERITONITIS. THERE WERE NO REPORTED ALLEGATIONS THAT THE PERITONITIS WAS RELATED TO ANY ISSUES WITH PRODUCTS. IN ADDITIONAL FOLLOW-UP, THE PD NURSE STATED THE PATIENT WAS HAVING SYMPTOMS OF ABDOMINAL PAIN AND CLOUDY PD EFFLUENT. AS A RESULT, ON (B)(6) 2023, THE PATIENT WAS SEEN IN THE OUTPATIENT PD CLINIC. THE PATIENT HAD A PD CULTURE OBTAINED WHICH GREW CANDIDA TROPICALIS. THE NURSE STATED THE PATIENT IS BEING TREATED WITH ANTIBIOTIC THERAPY USING ORAL FLUCONAZOLE (DOSE UNKNOWN) AND INTRAVENOUS VANCOMYCIN AND CEFTAZIDIME (DOSE UNKNOWN) ON AN OUTPATIENT BASIS. ADDITIONALLY, THE PATIENT WAS TRANSITIONED TO BACK UP HEMODIALYSIS FOR RENAL REPLACEMENT NEEDS AND WILL UNDERGO REMOVAL OF THE PD CATHETER (NOT A FRESENIUS PRODUCT). THE PATIENT¿S NURSE WAS NOT ABLE TO IDENTIFY THE EXACT CAUSE OF THE PATIENT¿S PERITONITIS IS UNKNOWN. HOWEVER, THE NURSE CONFIRMED THE PATIENT DID NOT HAVE ANY FLUID LEAKS OR ISSUES WITH FRESENIUS PRODUCTS IN RELATION TO THIS EVENT. THE NURSE REPORTED THE PATIENT IS RECOVERING FROM PERITONITIS EVENT.

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 18234119 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT'S CONTACT REPORTED THAT THIS PATIENT ON PD THERAPY HAS PERITONITIS. THERE WERE NO REPORTED ALLEGATIONS THAT THE PERITONITIS WAS RELATED TO ANY ISSUES WITH PRODUCTS. IN ADDITIONAL FOLLOW-UP, THE PD NURSE STATED THE PATIENT WAS HAVING SYMPTOMS OF ABDOMINAL PAIN AND CLOUDY PD EFFLUENT. AS A RESULT, ON 8/NOV/2023, THE PATIENT WAS SEEN IN THE OUTPATIENT PD CLINIC. THE PATIENT HAD A PD CULTURE OBTAINED WHICH GREW CANDIDA TROPICALIS. THE NURSE STATED THE PATIENT IS BEING TREATED WITH ANTIBIOTIC THERAPY USING ORAL FLUCONAZOLE (DOSE UNKNOWN) AND INTRAVENOUS VANCOMYCIN AND CEFTAZIDIME (DOSE UNKNOWN) ON AN OUTPATIENT BASIS. ADDITIONALLY, THE PATIENT WAS TRANSITIONED TO BACK UP HEMODIALYSIS FOR RENAL REPLACEMENT NEEDS AND WILL UNDERGO REMOVAL OF THE PD CATHETER (NOT A FRESENIUS PRODUCT). THE PATIENT¿S NURSE WAS NOT ABLE TO IDENTIFY THE EXACT CAUSE OF THE PATIENT¿S PERITONITIS IS UNKNOWN. HOWEVER, THE NURSE CONFIRMED THE PATIENT DID NOT HAVE ANY FLUID LEAKS OR ISSUES WITH FRESENIUS PRODUCTS IN RELATION TO THIS EVENT. THE NURSE REPORTED THE PATIENT IS RECOVERING FROM PERITONITIS EVENT.

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 18234118 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT WAS DIAGNOSED WITH AN INFECTION ON PD CATHETER (NOT A FRESENIUS PRODUCT). ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PDRN. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) ON (B)(6) 2023. NO SYMPTOMS WERE PROVIDED. THE PATIENT WAS DIAGNOSED WITH PERITONITIS. IT WAS CONFIRMED THIS WAS NOT A PD CATHETER INFECTION. THE PATIENT WAS INITIATED ON ANTIBIOTIC THERAPY WITH INTRAPERITONEAL (IP) VANCOMYCIN AND CEFTAZIDIME (DOSE, FREQUENCY, AND DURATION NOT PROVIDED). NO CULTURE RESULTS WERE AVAILABLE. THE PATIENT¿S HOSPITAL RECORDS HAVE NOT BEEN RECEIVED BY THE CLINIC. THE CLINIC HAS NOT BEEN ABLE TO OBTAIN INFORMATION FROM THE PATIENT, WHO HAS BEEN DIFFICULT TO GET IN TOUCH WITH SINCE THE ER VISIT. THE PATIENT IS REPORTEDLY NOT COMPLETING PD TREATMENTS. THE PATIENT STATED THE HOSPITAL INSTRUCTED HER NOT TO COMPLETE PD TREATMENTS. THE PDRN STATED THE HOSPITAL WOULD NOT INSTRUCT THE PATIENT TO WITHHOLD DIALYSIS. THE PATIENT HAS A HISTORY OF NON-COMPLIANCE WITH TREATMENTS. THEREFORE, IT IS UNKNOWN IF THE PATIENT IS COMPLIANT WITH THE ANTIBIOTIC THERAPY. THE CAUSE OF THE PERITONITIS HAS

  Patient problems: Peritonitis

  MAUDE report 18124508 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT WAS DIAGNOSED WITH AN INFECTION ON PD CATHETER (NOT A FRESENIUS PRODUCT). ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PDRN. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) ON (B)(6) 2023. NO SYMPTOMS WERE PROVIDED. THE PATIENT WAS DIAGNOSED WITH PERITONITIS. IT WAS CONFIRMED THIS WAS NOT A PD CATHETER INFECTION. THE PATIENT WAS INITIATED ON ANTIBIOTIC THERAPY WITH INTRAPERITONEAL (IP) VANCOMYCIN AND CEFTAZIDIME (DOSE, FREQUENCY, AND DURATION NOT PROVIDED). NO CULTURE RESULTS WERE AVAILABLE. THE PATIENT¿S HOSPITAL RECORDS HAVE NOT BEEN RECEIVED BY THE CLINIC. THE CLINIC HAS NOT BEEN ABLE TO OBTAIN INFORMATION FROM THE PATIENT, WHO HAS BEEN DIFFICULT TO GET IN TOUCH WITH SINCE THE ER VISIT. THE PATIENT IS REPORTEDLY NOT COMPLETING PD TREATMENTS. THE PATIENT STATED THE HOSPITAL INSTRUCTED HER NOT TO COMPLETE PD TREATMENTS. THE PDRN STATED THE HOSPITAL WOULD NOT INSTRUCT THE PATIENT TO WITHHOLD DIALYSIS. THE PATIENT HAS A HISTORY OF NON-COMPLIANCE WITH TREATMENTS. THEREFORE, IT IS UNKNOWN IF THE PATIENT IS COMPLIANT WITH THE ANTIBIOTIC THERAPY. THE CAUSE OF THE PERITONITIS HAS

  Patient problems: Peritonitis

  MAUDE report 18124476 ↗
• MalfunctionSep 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A LICENSED PRACTICAL NURSE (LPN) FROM A LONG-TERM CARE (LTC) FACILITY REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT A FLUID LEAK OCCURRED DURING A PATIENT'S PERITONEAL DIALYSIS (PD) TREATMENT. PRIOR TO DISCOVERY OF THE FLUID LEAK, IT WAS REPORTED THAT AN ¿M31 AIR DETECTED IN CASSETTE¿ ALARM OCCURRED DURING DRAIN 3 OF 6. THE LPN CONTACTED TS FOR ASSISTANCE IN BYPASSING THE ALARM. AFTER FAILING TO MOVE PAST THE ALARM, THE LPN WAS ADVISED TO RESETUP THE CYCLER WITH NEW SUPPLIES. WHEN THE LPN OPENED THE CYCLER DOOR, THE FLUID LEAK WAS DISCOVERED. THE LPN CONFIRMED THERE WAS NO VISIBLE DAMAGE ON THE BACK OF THE CASSETTE. THE ORIGIN OF THE LEAK WAS NOT KNOWN. THE PATIENT DID NOT COMPLETE THEIR TREATMENT. THE LPN SAID THE STAFF AT THE FACILITY WERE NEVER TRAINED TO PERFORM MANUAL PD EXCHANGES AS AN ALTERNATIVE TO USING THE CYCLER. THE LPN WAS ADVISED BY TS TO LET THE CYCLER DRY OUT AND WAIT A FULL 24-HOURS BEFORE USING IT AGAIN. IN ORDER TO DO THIS, THE PATIENT HAD TO MISS TREATMENT THE FOLLOWING DAY AS WELL. HOWEVER, THE LPN CONFIRMED THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, EXPERIENCE ANY ADVERSE EFFECTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17715830 ↗
• MalfunctionAug 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT CONTACT DISCOVERED A FLUID LEAK FROM A LOOSE STAY SAFE CONNECTOR DURING DWELL 3 OF 4 OF THE PATIENT¿S PD TREATMENT. FLUID WAS NOT DISCOVERED IN THE PUMP MODULE AREA. FLUID WAS NOT DISCOVERED 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. 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 NOT ABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT ON THE DAY OF THE REPORTED EVENT. THE NURSE STATED THAT PER THE CLINIC¿S PROCEDURE THE PATIENT WAS PRESCRIBED PROPHYLACTIC ANTIBIOTICS, VANCOMYCIN AND GENTAMYCIN. THE PDRN 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 HAS BEEN DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17605027 ↗
• MalfunctionAug 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK AFTER ENDING THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DRAIN 5 OF 6 OF TREATMENT AND THE TREATMENT WAS CANCELLED. THE PATIENT REBOOTED THE CYCLER BUT THE WARNING REOCCURRED. 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 AND FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. ADDITIONAL INFORMATION REQUESTED BUT HAS NOT BEEN OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17512203 ↗
• MalfunctionAug 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT CONTACT REPORTED VIA PHONE THAT THE PATIENT¿S LIBERTY CYCLER EXPERIENCED A FLUID LEAK WHICH WAS DISCOVERED DURING FILL 1 OF 4 OF DIALYSIS TREATMENT. THE PATIENT CONTACT REPORTED M31 AIR DETECTED IN CASSETTE WARNING ALARMS WHICH OCCURRED IN DRAIN 0 OF 4 OF TREATMENT AND PRIOR TO THE LEAK. THE PATIENT CONTACT STATED ALL LINES WERE SECURELY CONNECTED. FLUID WAS NOT DISCOVERED IN THE PUMP MODULE AREA OR ON THE EXTERNAL OF THE CASSETTE, AND FLUID WAS NOTED TO HAVE LEAKED FROM THE PATIENT'S CONNECTION TO THE PATIENT LINE. THE PATIENT CONTACT WAS ADVISED TO CANCEL TREATMENT. THE PATIENT CONTACT STATED THEY WOULD RE-SETUP WITH NEW SUPPLIES DUE TO THE FLUID LEAK. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM OR ADVERSE EVENT WAS REPORTED AS ASSOCIATED WITH THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17502241 ↗
• MalfunctionJul 25, 2023Fluid/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 AN UNKNOWN PHASE/CYCLE OF THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING NO ALARMS OR WARNINGS PRIOR TO OR AFTER THE LEAK. THE FILM ON THE BACK OF THE CASSETTE WAS NOT LOOSE. 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 NOT ABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT ON THE DAY 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. THE CYCLER SET USED BY THE PATIENT WAS DISCARDED, HOWEVER A COMPANION SAMPLE FROM THE SAME LOT, IS AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17389920 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043363, K173718. One submission often covers many models, so check the product and lot details in each record.

• Z-2085-2021 · Apr 28, 2021 · Terminated
  026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting
• 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
• Z-0693-2016 · Dec 15, 2015 · Terminated
  Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
• Z-0148-2014 · Oct 14, 2013 · Terminated
  Fresenius Liberty Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.
• Z-1674-2013 · Jun 3, 2013 · Terminated
  Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain lin
• Z-0799-2013 · Oct 12, 2012 · Terminated
  Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.
• Z-1448-2012 · Mar 30, 2012 · Terminated
  Fresenius Liberty Cycler Software, User Manuals, and Handi-Guides for acute and chronic peritoneal dialysis. Software versions earlier than 2.8. The Fresenius Liberty Cycler is in
• Z-0104-2011 · Sep 3, 2010 · Terminated
  LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Single Patient Connector) PIN: 050-87215. manufactured for Fresenius Medical Care, Waltham M
• Z-0105-2011 · Sep 3, 2010 · Terminated
  LIBERTY Automated Peritoneal Dialysis System lntegrated Cycler Set with single stay safe patient connector and extended drain line PIN: 050-87216. manufactured for Fresenius Medica
• Z-0103-2011 · Sep 3, 2010 · Terminated
  LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Dual Patient Connector) PIN: 050-87212, manufactured for Fresenius Medical Care, Waltham MA