stay.safe® 050-50758Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00840861100699), received between Nov 28, 2017 and Oct 2, 2025 — classified as 1 injury, 27 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (28 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 18, 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.

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

  IT WAS REPORTED THAT THE PATIENT WOKE UP AND DISCOVERED A FLUID LEAK DUE TO THE PIN ON THE PATIENT LINE BREAKING OFF DURING DRAIN 4 OF 4 OF TREATMENT. THE PATIENT EXPERIENCED DRAIN COMPLICATIONS. THE PATIENT CANCELED TREATMENT AND BEGAN DOING A MANUAL DRAIN. THE PATIENT WAS ADVISED TO CONTACT THEIR NURSE TO INFORM THEM OF THE REPORTED EVENT. UPON FOLLOW UP, THE PDRN CONFIRMED THAT THE PATIENT¿S SUPPLIES WERE CONNECTED CORRECTLY. THE FLUID LEAK CAME FROM THE BREAKING OFF OF THE PIN ON THE MULTIPLE TUBING SEGMENT (MTS) CONNECTION. IT WAS ALSO CONFIRMED THAT THE PDRN STATED THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED. THE PATIENT WAS PRESCRIBED PROPHYLACTIC ANTIBIOTICS, VANCOMYCIN 1750MG IP AND CEFTAZIDIME 2G IP ON (B)(6) 2025. 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 PATIENT IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE CYCLER SET USED BY THE PATIENT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23203104 ↗
• MalfunctionMar 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK ON THE PATIENT LINE OF THE CYCLER SET DURING DRAIN 1 OF 5 OF THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING A DRAINING SLOWLY ALARM DURING DRAIN 1 OF 5 OF TREATMENT PRIOR TO THE LEAK. THE BLUE PIN THAT IS CLOSEST TO THE PATIENT WAS NOT PUSHED IN BUT SOMEHOW THE CONNECTOR WAS CRACKED. THE PATIENT USED AN EXTENSION SET WITH THREE CONNECTORS; HOWEVER, THE FIRST CONNECTOR WAS CRACKED RESULTING IN THE FLUID LEAK. FLUID WAS NOT DISCOVERED IN THE PUMP MODULE AREA OR ON THE EXTERNAL OF THE CASSETTE. THE PATIENT WAS ADVISED TO RE-SETUP THE CYCLER WITH NEW SOLUTION BAGS AND NEW TUBING SET. UPON FOLLOW UP, THE PATIENT CONTACT CONFIRMED THE REPORTED FLUID LEAK EVENT OCCURRED FROM A CRACK AT THE CONNECTION BETWEEN THE PORT ON THE PATIENT AND THE EXTENSION SET. 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 AND THE CYCLER. THE PATIENT CONTACT CONFIRMED THAT THE PATIENT IS CONTINUING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21565016 ↗
• MalfunctionAug 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT REPORTED THAT THERE WAS FLUID FOUND LEAKING FROM THE PATIENT LINE CONNECTION DURING PD TREATMENT. FLUID WAS FOUND LEAKING DURING DWELL 1 OF 5. THERE WERE NO HOLES NOTED. THERE WAS NO FLUID INSIDE THE CYCLER MODULE AREA. IN A FOLLOW UP, THE PATIENT'S ROOMMATE SAID THE PATIENT DID NOT HAVE ANY HARM OR ADVERSE EVENT DUE TO THE LEAK. IN ANOTHER FOLLOW UP, THE PD NURSE VERIFIED THERE WAS NO HARM. THE MULTIPLE TUBING SEGMENT IS NOT AVAILABLE TO RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20090024 ↗
• MalfunctionApr 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT REPORTED A FLUID LEAK DURING PD TREATMENT. THERE WAS AN AIR DETECTED IN CASSETTE WARNING IN DRAIN 5 OF 6. THE PATIENT DISCOVERED FLUID LEAKING FROM THE CONNECTION BETWEEN THE MTS STAY SAFE AND THE CYCLER SET. IN A FOLLOW-UP, THE PATIENT VERIFIED THERE WAS NO HARM, INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THE FLUID LEAK. THERE IS NO SAMPLE MTS STAY SAFE SET. THE PATIENT IS USING THE SAME CYCLER AND CONTINUING TREATMENTS WITH NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19177544 ↗
• MalfunctionMar 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THE MULTI STAY SAFE CONNECTOR DURING DWELL 2 OF 6 OF THEIR PD TREATMENT. THE CAUSE OF THE LEAK IS UNKNOWN. THE PATIENT WAS ASSISTED IN CHANGING THE FLOW ALERT OPTION TO NO. 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 DISCARDED AND IS NOT AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18894382 ↗
• MalfunctionOct 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT REPORTED A FLUID LEAK FROM THE MULTIPLE TUBING SEGMENT DURING PD TREATMENT WHEN THE SYSTEM WAS DRAINING. THERE WAS NO HARM REPORTED IN THE INITIAL CALL. ADDITIONAL ATTEMPTS WERE MADE TO GATHER MISSING DETAILS, BUT NO DATA WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17914552 ↗
• MalfunctionAug 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THE SECOND CONNECTOR ON THE PATIENT LINE DURING THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING FILL 1 OF TREATMENT AND THE TREATMENT WAS CANCELLED. THE PATIENT WAS ADVISED TO RESET UP TREATMENT WITH NEW SUPPLIES. UPON FOLLOW UP, IT WAS CONFIRMED THAT THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED. THE PATIENT NOTED THAT THE BLUE RING FOLDED WHEN THE CONNECTOR WAS SCREWED ON. CONFIRMED NO FLUID CAME IN CONTACT WITH THE CYCLER. THE PATIENT WAS PRESCRIBED PROPHYLACTIC ANTIBIOTICS, HOWEVER, DESPITE THE PROPHYLACTIC ANTIBIOTICS, THERE WERE NO SYMPTOMS, ADVERSE EVENTS, OR INJURIES REQUIRING MEDICAL INTERVENTION REQUIRED 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 DISCARDED AND IS NOT AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17481393 ↗
• MalfunctionJun 30, 2023Fluid/Blood Leak; Fluid/Blood Leak

  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 1 OF 5. A FLUID LEAK WAS SUBSEQUENTLY DISCOVERED IN STEP 9 OF TREATMENT COMPLETE. THE PATIENT WAS NOT CONNECTED DURING THE INCIDENT. 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. UPON FOLLOWUP THE CLINIC MANAGER (CM) AT THE PATIENT¿S CLINIC CONFIRMED THE REPORTED EVENT. THE CM STATED THAT PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE CM COULD NOT CONFIRM IF THE PATIENT COMPLETED TREATMENT ON THE DAY OF THE REPORTED EVENT. THE CM CONFIRMED THE PATIENT HAS CONTINUED USING THE CYCLER FOR THEIR PD TREATMENT WITHOUT ISSUE SINCE. THE CM CONFIRMED THAT THE CYCLER SET WAS DISCARDED AND NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO DEFECT OR DAMAGE TO THE CYCLER SET CASSETTE WAS NOTED UPON REMOVING IT FROM THE CYCLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243830 ↗
• MalfunctionDec 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THEIR STAY SAFE CONNECTOR SET DURING THEIR PD TREATMENT. THE PATIENT REPORTED FLUID LEAKED OUT ALL OVER. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. UPON FOLLOW UP, THE PATIENT CONFIRMED BEING 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 STAY SAFE CONNECTOR SET USED BY THE PATIENT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15992537 ↗
• MalfunctionMay 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) REPORTED WHEN THEY PERFORMED A FLUSH ON THE PATIENT AND WAS REMOVING THE DISK FROM THE ORGANIZER, THEY NOTED A FLUID LEAK AT THE SITE WHERE THE DRAIN LINE CONNECTS TO THE DISK. THE PATIENT WAS DISCONNECTED BUT IT WAS UNKNOWN IF THE LEAK WAS THERE FROM THE START OF THE EXCHANGE OR HAPPENED AT THE TIME THE PDRN WAS REMOVING THE DISK. THE PDRN WAS ADVISED TO NOTIFY THE PHYSICIAN OF THE EVENT. THE SAMPLE WAS DISCARDED AND WAS NO LONGER AVAILABLE TO BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14342618 ↗
• InjuryDec 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT WAS DIAGNOSED WITH PERITONITIS. UPON FOLLOW UP, THE PD REGISTERED NURSE (PDRN) REPORTED THE PATIENT WAS SEEN IN THE PD CLINIC WITH COMPLAINTS OF ABDOMINAL PAIN. A PD EFFLUENT CULTURE WAS OBTAINED, AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS INITIATED ON INTRAPERITONEAL (IP) ANTIBIOTICS WITH VANCOMYCIN 2G AND CEFTAZIDIME 2G. THE PATIENT CONTINUED WITH IP CEFTAZIDIME DAILY AND RECEIVED A SECOND DOSE OF VANCOMYCIN ON (B)(6) 2021. THE PD EFFLUENT CULTURE RESULTED POSITIVE FOR ACINETOBACTER RADIORESISTENS. THE VANCOMYCIN WAS DISCONTINUED, AND THE PATIENT HAS CONTINUED TO TAKE CEFTAZIDIME 2G DAILY. THE CAUSE OF THE PATIENT¿S PERITONITIS EVENT WAS ATTRIBUTED TO THE REPORTED LEAK OF THE STAY SAFE MTS SET. THE PATIENT WAS NOT HOSPITALIZED FOR THIS EVENT AND CONTINUES TO COMPLETE TREATMENT UTILIZING THE LIBERTY SELECT CYCLER.

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 13099959 ↗
• MalfunctionJun 2, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THE STAY SAFE PIN OF THE PATIENT LIBERTY CYCLER SET. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DRAIN 1 OF 5 OF TREATMENT AND THE TREATMENT WAS CANCELLED. FLUID DID NOT COME IN CONTACT WITH THE CYCLER. THE PATIENT WAS ADVISED TO RE-SETUP TREATMENT WITH NEW SUPPLIES. UPON FOLLOW UP, THE PATIENT STATED 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 BY RESETTING-UP WITH NEW SUPPLIES. 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 REPORTED TO BE AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11926008 ↗
• MalfunctionMay 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM A PIN HOLE AROUND THE STAY SAFE CONNECTOR AREA AFTER ENDING THEIR PD TREATMENT. THE PATIENT AND PATIENT CONTACT WIFE WOKE UP FEELING THE BED MATTRESS AND SHEETS WERE SOAKED. THE PATIENT REPORTED RECEIVING A CANNOT TEACH PUMPS DURING SETUP ALARM DURING STEP 2 OF SETUP BUT WAS ABLE TO PASS ON STEP 3. THE CAUSE OF THE LEAK IS UNKNOWN. FLUID WAS NOT DISCOVERED IN THE PUMP MODULE AREA OR 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). A NEW CYCLER WAS ISSUED TO THE PATIENT. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS NOT AVAILABLE. UPON FOLLOW UP, THE PATIENT CONTACT CONFIRMED THE REPORTED FLUID LEAK EVENT OCCURRED BETWEEN THE PATIENT'S PD CATHETER AND THE MTS SET CONNECTION. THERE WERE NO OTHER FLUID LEAKS FOUND AT THE TIME. THE PATIENT CONTACT STATED THAT PER THE CLINIC¿S PROCEDURE THE PATIENT WAS PRESCRIBED PROPHYLACTIC ANTIBIOTICS, CEFAZOLIN (1 GRAM, INTRAPERITONEAL, 6 HOURS) AND CEFTAZADIME (1 GRAM, INTRAPERITONEAL, 6 HOURS). THE PATIENT CONTACT CONFIRMED THAT DESPITE THE PROPHYLACT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11886293 ↗
• MalfunctionMar 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THEIR MULTI-TUBING SET (MTS) DURING PD TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DRAIN 1 OF 7 OF TREATMENT AND THE TREATMENT WAS CANCELED. NO FLUID CAME IN CONTACT WITH THE CYCLER AND NO AIR BUBBLES WERE DETECTED DURING SETUP. IT WAS REPORTED THE PATIENT WOULD CANCEL TREATMENT AND RE-SETUP WITH NEW SUPPLIES. UPON FOLLOW-UP, THE PATIENT CONFIRMED THAT THE LEAK OCCURRED FROM THE MTS ONLY AND NO LEAK WAS FOUND FROM THE CASSETTE LINES OR CYCLER. THE PATIENT CONFIRMED THAT THEY DID NOT DEVELOP ANY SYMPTOMS, INJURY, ADVERSE EVENT, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT IS TRAINED ON PERFORMING MANUALS AND STAT DRAINS IF NEEDED, AND WAS ABLE TO COMPLETE TREATMENT BY RESETTING UP WITH NEW SUPPLIES. THE MTS WAS REPORTED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11416638 ↗
• MalfunctionFeb 25, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THE MULTI-TUBING SET (MTS) DURING DRAIN 2 OF 8 OF THEIR PD TREATMENT. THE PATIENT WAS ADVISED TO CANCEL THEIR TREATMENT AND FOLLOW-UP WITH THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). UPON FOLLOW-UP WITH THE PDRN, IT WAS REPORTED THAT THE LEAK OCCURRED BETWEEN THE PATIENT¿S MTS AND PD CATHETER (NON-FRESENIUS DEVICE). THE PDRN CONFIRMED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, INJURY, ADVERSE EVENT, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS ABLE TO COMPLETE TREATMENT BY RETIGHTENING THE CONNECTION. THE MTS PRODUCT SAMPLE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION BECAUSE IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11379661 ↗
• MalfunctionFeb 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THE TUBING LINES DURING FILL 1 OF THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING A DRAIN COMPLICATION ENCOUNTERED. PLEASE CHECK PATIENT LINE AND DRAIN LINE MESSAGE DURING DRAIN 1 OF 5 OF TREATMENT. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. THE FLUID DID NOT COME IN CONTACT WITH THE CYCLER. THE PATIENT WAS ADVISED TO CANCEL THEIR TREATMENT, RESET UP WITH NEW SUPPLIES, AND FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). UPON FOLLOW UP, THE PDRN STATED THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED. UPON FURTHER FOLLOW UP, 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 CONFIRMED THAT THE PATIENT WAS USING THE STAY SAFE MTS SET, A LIBERTY CYCLER SET, AND THE LIBERTY SELECT CYCLER DURING THIS EVENT. THE PATIENT CONTACT STATED THAT THEY BELIEVED THE FLUID LEAK OCCURRED FROM THE STAY SAFE MTS SET. THE PATIENT CONTACT STATED THAT IT IS UNKNOWN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11272215 ↗
• MalfunctionDec 22, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN AIR DETECTED IN CASSETTE ALARM DURING DRAIN 0 OF 6 OF TREATMENT. THE TREATMENT WAS CONTINUED AND A FLUID LEAK WAS DISCOVERED DURING FILL 1 FROM THE PIN OF THE MULTI-CONNECTOR. IT WAS REPORTED THAT THE LEAK WAS CAUSED BY A LOOSE PIECE OF PLASTIC FROM THE THIRD PIN OF THE MULTI-CONNECTOR. NO FLUID CAME IN CONTACT WITH THE CYCLER. THE PATIENT REPORTED THAT THEY WOULD RESET UP WITH NEW SUPPLIES. ADDITIONAL INFORMATION WAS REQUESTED BUT TO DATE, HAS NOT BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11055112 ↗
• MalfunctionSep 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THE MULTI SEGMENT CONNECTOR DURING FILL 1 OF 3 OF THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DRAIN 0 OF 3 OF TREATMENT. THE PATIENT REPORTED THAT THREE OR FOUR AIR BUBBLES WERE FOUND IN THE DRAIN LINE. THE PATIENT CONTACTED TECHNICAL SUPPORT FOR ASSISTANCE WITH BYPASSING TO FILL 1 BECAUSE THEY WERE EMPTY. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE PATIENT REPORTED THAT THE CAUSE OF THE LEAK WAS A LOOSE CONNECTION OF THE MULTI SEGMENT CONNECTORS. THE PATIENT REPORTED THAT FLUID LEAK CONSISTED OF 4 DROPS OF LIQUID. THE FLUID LEAK DID NOT COME IN CONTACT WITH THE CYCLER. THE PATIENT WAS ADVISED TO RESET UP THEIR CYCLER, BUT THE PATIENT REFUSED. THE PATIENT TIGHTENED THE MULTI SEGMENT CONNECTOR AND THAT HAD RESOLVED THE PROBLEM. THE PATIENT WAS ABLE TO COMPLETE FILL 1 AND CONTINUE THEIR TREATMENT. UPON FOLLOW UP, THE PATIENT STATED THAT THEY ARE TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED. THE PATIENT STATED THAT THEY WERE ABLE TO COMPLETE TREATMENT. THE PATIENT STATED THAT THE FLUI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10583515 ↗
• MalfunctionAug 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT WANTED TO CANCELED TREATMENT DURING DWELL OF TREATMENT DUE TO THEIR MULTI SEGMENT ATTACHMENT CRACKING AND FLUID LEAKING ALL OVER THE FLOOR. THERE WASN¿T ANY FLUID OBSERVED ON THE CYCLER. THE PATIENT WAS ADVISED TO RESET UP WITH NEW SUPPLIES. UPON FOLLOW UP, THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS ABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT USING THE CYCLER AFTER SETTING UP WITH NEW SUPPLIES. THE PATIENT IS CONTINUING WITH PERITONEAL DIALYSIS ON THE 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 8905865 ↗
• MalfunctionJul 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A PERITONEAL DIALYSIS (PD) PATIENT HAD A LEAK WITH THEIR STAY SAFE MTS SET. UPON FOLLOW-UP WITH THE PATIENT'S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) IT WAS 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 IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED, AND STATED THE PATIENT WAS ABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT ON THE CYCLER. THE PDRN CONFIRMED THAT THE MTS SET 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 8789267 ↗
• MalfunctionJul 3, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK WITH THEIR STAY SAFE MTS SET DURING 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, THE PERITONEAL DIALYSIS REGISTERED 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 TREATMENT ON THE CYCLER. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE STAY SAFE MTS SET 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 8757813 ↗
• MalfunctionMay 28, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED A FLUID LEAK WITH THEIR STAY SAFE MULTIPLE TUBING SEGMENT (MTS) SET AT THE PATIENT CONNECTION DURING THEIR PD TREATMENT. AT THAT POINT IN TIME, THE FRESENIUS TECHNICAL SUPPORT REPRESENTATIVE ADVISED THE PATIENT TO RESET UP WITH NEW SUPPLIES. UPON FOLLOW-UP WITH THE PATIENT'S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN), IT WAS CONFIRMED THAT THE PATIENT DID NO EXPERIENCE ANY INJURY, ADVERSE EVENT, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS ABLE TO COMPLETE TREATMENT BY SETTING UP WITH NEW SUPPLIES. THE MTS SET IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8647507 ↗
• MalfunctionJan 2, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK AT THE TUBING BETWEEN THE CASSETTE AND THE STAY SAFE CONNECTOR DURING FILL 1 OF THEIR PD TREATMENT. THE PATIENT WAS ADVISED TO DISCONTINUE THE USE OF THEIR CYCLER. UPON FOLLOW UP, THE PERITONEAL DIALYSIS NURSE (PDRN) STATED THE PATIENT WAS ABLE TO COMPLETE THEIR TREATMENT AFTER SETTING UP WITH NEW SUPPLIES. 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 CASSETTE AND THE STAY SAFE CONNECTOR USED BY THE PATIENT WERE DISCARDED AND ARE NOT AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8210172 ↗
• MalfunctionAug 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT REPORTED THAT THE STAY SAFE MTS SET TUBING SEEMS TO LEAK DURING PERITONEAL DIALYSIS TREATMENT. THERE WAS NO INDICATION OF THE PATIENT ENCOUNTERING CYCLER ALARMS. FOLLOW UP WITH THE PATIENT¿S PERITONEAL DIALYSIS NURSE INDICATES THAT THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS AS A RESULT OF THE ALLEGED EVENT. ADDITIONAL INFORMATION WAS SOLICITED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7788632 ↗
• MalfunctionMay 14, 2018Fluid/Blood Leak; Fluid/Blood Leak

  PERITONEAL DIALYSIS PATIENT CALLED DURING TROUBLESHOOTING WITH TECHNICAL SUPPORT OF OBSERVING A FLUID LEAK AT THE STAY SAFE CONNECTION DURING PRIMING OF THE CYCLER. IT IS UNKNOWN IF THE PATIENT WAS FILLING OR DRAINING AT THE TIME. ADDITIONAL INFORMATION WAS SOLICITED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7513130 ↗